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 an inspection from November 12 to 25, 2019, and observed the violations of current Good Manufacturing Practice (cGMP).

The FDA came into the conclusion that the company quality system does not comply with the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured.

The violations are as follows:-

Unofficial HPLC Injections

When the analytical records were reviewed during the inspection, it was observed that the samples injected on the high-performance liquid chromatography (HPLC) system were not included in the laboratory records used by the Quality Unit. The laboratory management failed to provide an adequate explanation to the FDA investigators.

Improper Security Control for equipment

The company failed to possess accurate security controls to prevent unauthorized manipulation of laboratory electronic data. The employees shared a common log-in password to access the Infrared Spectrophotometer (IR) system.

Inappropriate Tests Methods

The company could not assure that their test methods were appropriate for their intended use. Some methods resulted in abnormal peaks, missing integration, and required blank injections between samples. It stated that the laboratories should establish and validate analytical methods and procedures to ensure robustness and consistency of testing.  

Lack of adequate investigations into drug product complaints.

The drug product complaints were left unresolved without determining the root cause.

Misbranding Violations

FDA criticized the false claims observed on the product labels on the company’s website. The label claim on the product did not comply with the cGMP regulations and henceforth failed FDA approval for being sold in the U.S. market.

Therefore, USFDA came to the conclusion that the quality system of Tender Corporation was inadequate. The FDA also recommended engaging a consultant for assisting in meeting up with the CGMP requirements.