Indian biopharma company Biocon was issued 10 observations after the U.S. FDA found cGMP lapses at the drugmaker's small molecule injectable plant in Bengaluru.
The Form 483 was issued after an inspection between May 25 and June 3.
According to the FDA, inspectors observed inadequate procedures by the company to prevent microbiological containment of drug products, unexplained discrepancy in batches of the same product, incomplete data in lab records, and deficient procedures for the cleaning and maintenance of equipment, among other issues.
Additionally, the FDA said that the employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions.
According to Biocon, the company has responded to the FDA with a Corrective and Preventive Action Plan and is on track to implement them in a timely manner.
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