Zydus Cadila sent warning letter after FDA finds microbiology problems

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The FDA has sent a warning letter to Cadila Healthcare’s Ahmedabad, India finished products plant after an inspection found GMP deviations.

Inspectors from the US Food and Drug Administration (FDA) visited the plant in January and found significant violations from good manufacturing practices (GMP). Having reviewed Cadila’s response the FDA still has concerns about microbiology practices at the facility.
“We are concerned that trained microbiologists employed by your firm were unable to accurately identify microbial growth on environmental monitoring plates. Additionally, there is no assurance that such errors have not occurred previously”, said the FDA in its warning letter to Cadila .

In the letter the FDA emphasises the importance of having “accurate and reliable microbiological data” to support aseptic processing operations used during the production of sterile finished drug products.

Problems raised by the FDA fall into two broad categories.
Firstly: “Cadila’s laboratory records fail to include complete data derived from all tests necessary to assure compliance with established specifications and standards.”
Secondly: “Cadila has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile.”

Responses: Cadila has retrained staff in light of concerns about microbiological practices and the FDA has asked for details of the process. The FDA asked about a discrepancy between the numbers of quality control staff attending each training session and also wants a copy of the documents.

Furthermore, the FDA asked Cadila for a corrective plan. The warning letter said: “Provide a more comprehensive corrective action plan to ensure the integrity of all data used to assess the quality and purity of all drugs manufactured at your facility, including any registration lots.”


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