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Reine Lifescience and North Carolina-based contract manufacturing organization (CMO) Ei LLC warned by USFDA for good manufacturing practice (GMP) violations

USFDA has issued a warning letter to Reine Lifescience after carrying out the inspection at company’s Gujarat facility in October and November 2017. FDA has recommended the company to hire a GMP consultant who can help them to address the observations found during the inspection and is requesting that the company conduct an investigation into its data integrity issues.

The observations noted during the inspection were as mentioned below:

1) Analytical data was found in a folder normally used for product development that contained batch data for API that “appeared to differ significantly from recorded test results.
2) The audit trail feature was disabled on instruments used for quality control testing, including the company’s high-performance liquid chromatography system
3) Analytical systems at the facility lacked controls to prevent staff from deleting or changing electronic data.
4) The company released and shipped API intended for the US market that were manufactured using the same equipment used to make other products, without validating their equipment cleaning processes.

Along with Reine Life science, FDA has also issued warning letter to Ei LLC at its North Carolina facility for the inspection carried out in October 2017. The observations noted during the inspection were as mentioned below:

1) The company manufactured topical drugs and pesticides using the same equipment in the same building. It is against cGMP rules to continue manufacturing drugs using the same equipment that is used to manufacture pesticides or other non-pharmaceutical products due to the risk of cross-contamination.
2) The company did not adequately validate its cleaning procedures to ensure against cross contamination between different drugs manufactured using the same equipment.
3) Ei failed to thoroughly investigate unexpected discrepancies in certain batches of its products, including out-of-specification results for batches of products that were produced using the same equipment as it used to make pesticides and for other commercial manufacturing.