12-01-2023 WHO raises an alert on cough syrups manufactured by Marion BiotechThe World Health Organisation (WHO) has raised a warning on two cough syrups manufactured by Uttar Pradesh-based Marion Biotech Pvt Ltd, which were considered as the ca |
21-12-2022 FDA Warning Letter issued for Data Integrity and Good Documentation Practice FailuresThe U.S. American company Kari Gran Inc. received the U.S. FDA Warning Letter pertaining to its site inspection in July 2022. The s |
21-12-2022 FDA Warning Letter to Glenmark for Laboratory IssuesGlenmark Pharmaceuticals Limited received a Warning letter from the U.S. FDA (Food and Drug Administration). The Warning Letter summarizes substantial violations of Cur |
21-12-2022 European Medicines Agency necessitates Clinical Trials Information System in 2023Starting 31 January 2023, the new Clinical Trials Information System (CTIS) will become mandatory as per EMA. CTIS functions as a single entry point of contact for the |
20-12-2022 Expert Task Force issues the latest version of the CCS GuidelineAfter February, the ECA Foundation's CCS Task Force issued a fresh version of a Contamination Control Strategy (CCS) Guideline to help its members meet this requirement |
13-12-2022 European Commission: Position paper on 'hybrid audits'In early December, the European Commission's MDCG (Medical Device Coordination Group) published a definition of 'hybrid audits'. Th |
08-12-2022 ICH: Final Q13 Guideline on Continuous ManufacturingThe ICH Q13 Guideline on "Continuous Manufacturing of Drug Substances and Drug Products (Step 4)" was eventually adopted during the International Council for Harmonisat |
07-12-2022 EC: Modified Labelling Requirements for IMPsWith the publishing of Delegated Regulation 2022/2239, the European Commission has issued the revised and amended labelling prerequisites for unauthorized investigation |
03-12-2022 Access Consortium Good Manufacturing Practice (GMP) StatementGood Manufacturing Practice (GMP) certifies that medicinal products are regularly produced and controlled to the quality standards relevant to their purposeful use or a |
02-12-2022 Standard for Serialisation and Data Matrix Codes begins on 1 January 2023Medicines-Standard for Serialisation and Data Matrix Codes Therapeutic Goods Order 2021 (TGO 106) begins on 1 January 2023. If Medi |
17-11-2022 European Medicines Agency (EMA): Q&A Documents on Centralized Procedures revised againThe Questions & Answers (Q&A) documents pertaining to centralized marketing authorization procedures, which were revised in June, have now been updated and publ |
15-11-2022 FDA issues Warning Letter to Abraxane Manufacturing unit for Sterility IssuesThe FDA issued a Warning Letter to Abraxis Bioscience LLC in Phoenix, United States, on October 31 2022. As per the warning notice, the FDA’s inspection of the co |
05-10-2022 The FDA issues Warning Letter to a Sterile Medicinal Products Manufacturer in the USThe FDA issued a Warning Letter to Cangene BioPharma, LCC, in Baltimore, a subsidiary of Emergent BioSolutions. Significant deviations from Current Good Manufacturing P |
08-04-2022 "Magic Heal" Manufacturer Receives FDA Warning LetterThe U.S. FDA (Food and Drug Administration) issued a Warning Letter dated March 14, 2022, to an American manufacturer- Premier Trends LLC. During a check from September |
26-01-2022 Inefficient OOS Analyses lead to FDA Warning LetterRecently the U.S. FDA (Food and Drug Administration) gave a warning letter to Professional Disposables International, Inc, located in Orangeburg, New Y |
14-01-2022 USFDA issues a warning letter to Aurobindo Pharma for its API facilityAurobindo Pharma received a warning letter from the USFDA for its Hyderabad-based Unit I, an active pharmaceutical ingredient (API) manufacturing facility.
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13-10-2021 FDA issues Warning Letter to Laboratorio Pharma International SRL for Lack of Stability Data and Specifications for APIsA recent Warning Letter from FDA to Laboratorio Pharma International SRL describes fundamental GMP deficiencies in the quality control area at its manufacturing facility of topical analgesics. |
18-08-2021 FDA issues Warning Letter highlighting the importance of Analytical Methods Validation and System Suitability TestsThe USFDA (Food and Drug Administration) inspection of the drug manufacturing facility, BBC Group Limited, China, from March 22 to March 26, 2021, revealed significant violations of Current Good Ma |
24-06-2021 WHO ‘identifies issues’ at Sputnik V vaccine manufacturing plant in MoscowThe WHO (World Health Organization) uncovered some problems at a Sputnik V vaccine filling site in Moscow related to the implementing an appropriate Environmental Monitoring Program to monitor and |
11-03-2021 COVID-19 Packaging Changes: Glass Vials and Stoppers- New FDA GuidanceCOVID-19 injectable products may need some changes to the primary packaging components (e.g., glass vials and stoppers). The supply chain issues are affecting vaccine availability. Hence, the U.S. |
10-03-2021 US health regulator issued three observations for New York API manufacturing plant: Dr Reddy's LabDr Reddy's Laboratories, an integrated pharmaceutical company, said that the US health regulator had issued a Form 483 with three observations after inspection of its manufacturing facility in Midd |
10-03-2021 Draft Guidance on GMP for Investigational Radiopharmaceutical Products: WHO/IAEAWHO published a 31-page draft guideline, "GMP for investigational radiopharmaceutical products," in March 2021. It offers recommendations for minimum standards in the manufacture |
05-03-2021 Vivimed's FDF facility in Jeedimetla: Ukraine GMP approval
Vivimed Labs Limited declared that its FDF manufacturing facility located in Jeedimetla, near Hyderabad, has been approved and accredited with GMP certification effective September 2 |
04-03-2021 Approved changes in inspection report for compliance with GMP: Ministry of Justice
The Ministry of Justice of Russia registered an order of the Ministry of Industry and Trade of Russia dated 29.01.2021 No. 284, which amends Annex 2 to the order of the Ministry of I |
03-03-2021 Warning Letter to Allay Pharmaceuticals: FDA criticizes Supplier Qualification |
23-01-2021 Guidance document released for monographs drafting & formatting for Indian Pharmacopoeia: IPCThe Indian Pharmacopoeia Commission (IPC) issued the Guidance Document for Drafting and Formatting Monographs for Indian Pharmacopoeia (IP) for guidance to the stakeholders, including drug analysts |
05-01-2021 Inadequate Quality Unit, Laboratory Controls, Sampling Plans, and Stability Program: FDA Warning Letter to Clientele, Inc.
The U.S. FDA (Food and Drug Administration) sent a Warning Letter to Clientele, Inc. The firm produces OTC topical drug products that include sunscreen act |
26-10-2020 Virtual inspections because of COVID-19 pandemic: Indian pharma industry calls on USFDA
Indian pharma industry urged the US FDA to conduct inspections of their plants and facilities virtually in the wake of the COVID-19 pandemic. The USFDA, in March, had suspend |
22-10-2020 USFDA issued a warning letter to the New Jersey unit of Aurobindo Pharma's subsidiary
The United States Food and Drug Administration (USFDA) issued a warning letter to the drug manufacturing company Aurobindo Pharma's step-down subsidiary. The warning was issued to th |
14-10-2020 FDA issues warning letter to Coupler Enterprises for GMP deficiencies in packaging
US-FDA recently issued a Warning Letter to Coupler Enterprises, a pharmaceutical manufacturer, for GMP deficiencies in its packaging and quality assurance. The warning is related to |
03-09-2020 Mylan's Indian Unit Received USFDA Warning Letter
Mylan NV received a warning letter from the U.S. FDA for failure in ensuring the purity of active pharmaceutical ingredients made at one of its plants in Pashamyl |
30-08-2020 Warning Letter closed for Dr Reddys Labs’ three Sites: USFDA
The US health regulator closed the warning letter of a pharmaceutical company, Dr Reddy's Laboratories, for three of its sites in Andhra Pradesh and Telangana, after due evalua |
21-08-2020 High levels of NDMA detected in Metformin Hydrochloride, prompted product recall
Bayshore was notified by U.S. Food and Drug Administration (USFDA) that certain batches of Metformin Hydrochloride Extended-Release Tablets, USP 750mg, and USP 500mg when tested for |
20-08-2020 FDA furnishes guidelines for the quantity of Bioavailability and Bioequivalence samples retained under 21 CFR 320.38(c)
The FDA has released compliance guidelines on reserve samples used in the bioavailability and bioequivalence studies. The guidelines:- &n |
19-08-2020 Tender Corporation receives a warning letter by USFDA for unapproved HPLC Injections and OCT products
Tender Corporation, the firm that manufactures and distributes OTC products receives a warning letter from The U.S. Food and Drug Administration. The FDA investigators conducted |
19-08-2020 Warning letter issued to Stason Pharmaceuticals for violating current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
The USFDA inspected the drug manufacturing facility of Stason Pharmaceuticals, Inc., and observed significant violations of current Good Manufacturing Practice regulations for finish |
12-08-2020 USFDA furnishes new guidelines on quality considerations for clinical research with Cannabis and Cannabis-derived compounds
Cannabis is the genus of the plant belonging to the Cannabaceae family. The three main species of Cannabis are C. sativa L., C. indica, and C. ruderalis. These spe |
10-08-2020 Voluntary recall of ChloraPrepTM Applicator due to possible fungal contamination
BD (Becton, Dickinson and Company), a leading global medical technology company announced voluntary recall for its product ChloraPrepTM 3ml applicator due to fungal c |
04-08-2020 Warning letter issued to Eskbiochem S.A. by USFDA, regarding the distribution of substandard and dangerous hand sanitizers.
FDA reiterates hand sanitizers comprising low levels of ethyl alcohol or isopropyl alcohol with the dangerous presence of methanol manufactured by Eskbiochem S.A. de C.V. The |
11-03-2020 Cadila's Baddi unit was furnished with USFDA Form 483 with zero observations
Cadila Healthcare Limited declared that US Food and Drug Administration (FDA) furnished Form 483 with zero observations to the Baddi unit of the company. |
09-03-2020 Hyderabad facility of SMS Pharma clears USFDA inspection
SMS Pharmaceuticals has successfully completed its Hyderabad’s testing facility regulatory inspection by the US drug regulator. The United States Fo |
02-03-2020 FDA issues warning letter to manufacturing facility of KVK-Tech
The US Food and Drug Administration (FDA) have issued a warning letter to drug manufacturing facility of KVK-Tech following an audit in April 2019.
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29-02-2020 Aurobindo Pharma receives EIR from USFDA for Hyderabad facility
Aurobindo Pharma Limited stated that it has gained the Establishment Inspection Report (EIR) with Voluntary Action Initiated (VAI) status from US Food and Drug Administrati |
29-02-2020 API Manufacturing Facility for Biocon Small Molecules Completed its Post -Approval and GMP USFDA Inspection
Biocon, a drug API maker, has announced that the U.S. Food and Drug Administration (FDA) performed a Post-Approval and GMP inspection of Small Molecules API Manufacturing F |
28-02-2020 Jadcherla facility of Shilpa Medicare receives 15 observations from USFDA
Shilpa Medicare has got 15 observations from US Food and Drug Administration (FDA) for the finished dosage formulation facility (sterile and non-sterile) for Jadcherla faci |
24-02-2020 USFDA concluded evaluation at Puducherry & Mangaluru facilities of Solara
A leading active pharmaceutical ingredient (API) provider, Solara Active Pharma Science Ltd., declared that the US Food and Drug Administration (FDA) have done two successf |
24-02-2020 USFDA retracted status of VAI for Unit-IV plant of Aurobindo Pharma
The US Food and Drug Administration (FDA) revoked the status of ‘Voluntary Action Initiated’ (VAI) furnished to Unit-IV plant of Aurobindo Pharma in Hyderabad.< |
24-02-2020 Alkem Labs Baddi facility receives 2 USFDA observations
Alkem Laboratories Limited has achieved 2 observations from US Food and Drug Administration (FDA) for the facility in Baddi of company in Himachal Pradesh. The company stated |
23-02-2020 EU GMP Annex 1: 2nd Draft on Sterile Manufacture
A 1st targeted consultation to the Annex 1 of the EU GMP Guide permitted about 140 companies and organizations to comment. The drafting group moved ahead with more than 6200 lines of |
22-02-2020 Reopening of investigation by USFDA of unit 4 facility of Aurobindo
Reopening of investigation of Aurobindo Pharma’s Unit-4 manufacturing facility by the US Food and Drug Administration, days after the regulator had declared that it h |
22-02-2020 Biocon receives three observations from USFDA for insulin facility in Malaysia
Biocon on Saturday stated that it has gained 3 observations from the US health regulator following inspection of its facility of insulin manufacturing in Malaysia. The US Foo |
22-02-2020 FDA Warning Letter for getting drugs which are potentially unsafe
The U.S. Food and Drug Administration (FDA) have furnished a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for getting drugs which are po |
22-02-2020 As per the Warning Letter, FDA criticizes Supplier Qualification
Supplier Qualification and the respective contracts in outsourcing activities are always hot debated topics in inspections. The U.S. Food and Drug Administration (FDA) rece |
11-02-2020 US FDA inspection at Panoli, Gujarat facility completed successfully of J. B. Chemicals & Pharmaceuticals Ltd
J. B. Chemicals & Pharmaceuticals Ltd’s US FDA granted solid oral dosage forms formulations manufacturing facility at Panoli, Gujarat has successfully completed p |
27-01-2020 Form 483 to Biocon's API facility: USFDA
A pre-approval inspection and good manufacturing practice examination was conducted by the US health regulator at the API manufacturing facility of Biocon. The company has received a |
16-01-2020 FDA furnishes warning letter to Health Pharma for violations of cGMP
The US Food and Drug Administration (FDA) has issued a warning letter to Health Pharma regarding its manufacturing site in New Jersey, US, after violations of current good manuf |
14-01-2020 Multiple manufacturing units of Lupin now under USFDA scanner
Drug major manufacturing capabilities of Lupin have come under the scanner of the US drug regulator, as it has located deficiencies across multiple sites in recent inspections. |
13-01-2020 USFDA categorizes inspection of Tarapur facility of Lupin as Official Action Indicated
Lupin Ltd on Monday stated the US health regulator has alerted that its Tarapur manufacturing facility may be subjected to regulatory actions. The company has obtained a comm |
11-01-2020 Lupin receives two observations from USFDA for Nagpur facility
Lupin, a drug firm on Saturday stated that it has obtained two observations from the US health regulator following the inspection of its Nagpur manufacturing facility. A PAI |
06-01-2020 GPT Pharma obtains US FDA warning for violations of cGMP at Hyderabad plant
The United States Food and Drug Administration (FDA) has furnished warning letter to drug firm GPT Pharmaceuticals for important violations of current good manufacturing practice (cG |
21-12-2019 EIR secured from USFDA by Pashamylaram facility of Suven Life Sciences
Suven Life Sciences Limited recently received the EIR following the renewal inspection by US health regulator at their facility in Pashamylaram near Hyderabad for the supply and |
19-12-2019 LifeSan Clinical Research obtains zero 483 observations from USFDA
A division of Centaur Pharmaceuticals Pvt Ltd, LifeSan Clinical Research has obtained zero Form 483 observations from US Food and Drug Administration (FDA). The company has unde |
19-12-2019 Baddi manufacturing unit of Glenmark obtains GMP certificate from European regulator
Glenmark Pharmaceuticals Ltd has obtained Certificate of good manufacturing practice (GMP) from European drug regulator for its Baddi unit in Himachal Pradesh. Glenmark's Baddi |
13-12-2019 Zero observation obtained by Hikal from US FDA for Panoli facility
Hikal Ltd has successfully completed USFDA audit at Panoli, Gujarat, with zero Form 483 observations. The inspection was conducted between September 9 and 13, 2019. |
25-11-2019 Torrent Pharma warned by USFDA for significant violations at US plant
The US health regulator has warned Torrent Pharmaceuticals’ US-based subsidiary for violating good manufacturing practices, including the unavailability of properly designed eq |
15-11-2019 USFDA found cGMP violations were found by at Cadila’s Moraiya plan
Vital violation of current Good Manufacturing Practice (cGMP) regulations was found by the health regulator of US for finished pharmaceuticals at Cadila Healthcare’s Morai |
18-10-2019 US FDA EIR to Lupin for Nagpur facility
Lupin Limited received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Nagpur facility. Inspection of the facility was done by the US |
17-10-2019 Torrent Pharma red flagged by USFDA for violating norms for Indrad Facility
Torrent Pharma is now red flagged by USFDA for significant violations of current good manufacturing practice (cGMP) regulations for its Indrad facility in Gujarat. An inspect |
13-10-2019 Torrent Pharma recalls 74k bottles of hypertension drug from US
As per the reports of the US health regulator, Torrent Pharma Inc is recalling 73,896 bottles of hypertension treatment tablets from the US and Puerto Rico on the basis of deviations |
10-10-2019 USFDA observations to Aurobindo Pharma's Unit-VII regarding potentially misleading documents
An inspection has been conducted by the US Food and Drug Administration officials in a manufacturing facility of Aurobindo Pharma. The FDA has observed several discrepancies regardin |
09-10-2019 GMP certification for Lupin's unit-2 Mandideep facility by Japan's PMDA
Good manufacturing practice (GMP) certificate has been received by Lupin from Japan's Pharmaceutical and Medical Devices Agency (PMDA) for its drug manufacturing facility at Mandidee |
08-10-2019 FDA Warning Letter for Refusal to Permit Inspection: Important parameters for Startups and Drug and Device Manufacturers
Current Good Manufacturing Practices (cGMPs) are mandatory enforced by regulators of the U.S. Food and Drug Administration (FDA), and must be executed and followed by manufacturers o |
05-10-2019 Mandideep facility of Lupin red-flagged by USFDA for CGMP violations
Lupin, a pharma firm was red flagged by the US health regulator for significant violations of the current good manufacturing practice regulations at its Mandideep facility in Madhya |
22-09-2019 USFDA cGMP surveillance clearance of Unichem Labs API facility in Kolhapur
Unichem Laboratories has successfully completed the US health regulator audit of its new facility at Kolhapur, Maharashtra without any observations. The cGMP surveillance of |
10-09-2019 USFDA warning letter to Hangzhou Badi Daily Use Chemical CompanyThe U.S. Food and Drug Administration (FDA) conducted an inspection of Hangzhou Badi Daily Use chemical company, drug manufacturing facility located at Huzhou City, Zhejiang Province from March 19 |
10-09-2019 Enprani Co., Ltd. Gets USFDA warning letterEnprani Co., Ltd drug manufacturing facility located at Incheon, was inspected by the U.S. Food and Drug Administration (FDA) from March 11 to 15, 2019. The warning letter was issued to com |
03-09-2019 Haw Par Healthcare Limited receives USFDA warning letterUSFDA inspection was done at Haw Par Healthcare Limited drug manufacturing facility located at Singapore, from February 25 to March 1, 2019. Issued warning letter summarized the significant |
27-08-2019 EMA cGMP certification to ViralgenThe Viralgen receives the European Medicines Agency (EMA) cGMP compliance accreditation certificate and Spanish Agency for Medicines and Health Products (AEMPS) Pharmaceutical Laboratory authorizat |
27-08-2019 Open-ended AGES GMP certification wins by Rentschler Fill SolutionsThe Austrian Agency for Health and Food Safety (AGES) has given the GMP compliance and pharmaceutical manufacturing license to the Rentschler Fill Solutions. It is a contact development and manufac |
27-08-2019 Three US FDA observations to Ipca Labs for Silvassa facilityThe US FDA inspection for Silvassa facility of Ipca Labs conducted during 19-23 August 2019. It is the formulation facility of Ipca Labs. The firms receive three US FDA observations in Form |
27-08-2019 Three US FDA observations to Ipca Labs for Silvassa facilityThe US FDA inspection for Silvassa facility of Ipca Labs conducted during 19-23 August 2019. It is the formulation facility of Ipca Labs. The firms receive three US FDA observations in Form |
14-08-2019 New Q&A’s added by FDA to lab control section-cGMP guidanceThree new questions and their answers are added by the USFDA to the laboratory Controls on Current Good Manufacturing Practices (cGMP) guidance. The instrument calibration standards, trial injectio |
12-08-2019 API facility of Natco Pharma gets 6 observations from the USFDAThe API facility based in Mekaguda Village, near Hyderabad receives six observations from the USFDA. The inspection was carried out between05-09 August 2019. The received observations are m |
10-08-2019 Strides Alathur facility completes USFDA inspection with no observationsThe Alathur facility of Strides based in Chennai has successfully completed the USFDA audit with zero observation. The inspection was done between 05August to 09August 2019 with no observation from |
05-08-2019 Lupin receives FDA EIR for Aurangabad facility
The USFDA has issued Establishment Inspection Report (EIR) for Lupin's Aurangabad facility. The USFDA inspection was carried out during 6 May 2019 till 15 May 2019. The Auran |
04-08-2019 Manufacturing violations observed at Emcure Pharma Pune Plant: USFDAThe US FDA has issued a warning letter to Emcure Pharma for its Pune based plant. It was made due to violation of current good manufacturing practices (cGMP) by the organization. The US FDA |
01-08-2019 Cadila Healthcare completes USFDA audit with zero observationThe USFDA has done the audit of Cadila Healthcare’s facility based at Ankleshwar in Gujarat. The facility is involved in the manufacturing of active pharmaceutical ingredients. The US |
31-07-2019 Vials for hemophilia treatment recalled by Bayer due to mislabelingAfter the fear of mislabeled vials, Bayer has voluntarily recalled 2 lots of 2000 IU vials (recombinant) containing Kogenate FS antihemophilic factor in the United States. Even though the labels in |
29-07-2019 Granules India’s inspection with one USFDA observationGranules India completes the USFDA audit of its Bonthapally facility with one observation. It is amongst the world’s largest single site manufacturing plant of Paracetamol API by volume. The |
23-07-2019 Patients are advised not to use Herbal Doctor Remedies’ MedicinesThe FDA has recommended that the patients should not use the drugs manufactured by Herbal Doctor Remedies, Monterey Park, California, because the conditions at the manufact |