Zydus Lifesciences Limited

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 2

You failed to adequately investigate contamination identified in your drug products.

Passage 3

Your firm failed to adequately investigate and determine the root cause of glass particulate contamination in multiple batches of Cyanocobalamin Injection USP 1000mcg/mL, 1mL found out of limits (OOL) or above alert limits. Without identifying a root cause, you conducted successive visual inspections of batches until glass particulates were within specification and then released batches of Cyanocobalamin Injection USP 1000mcg/mL, 1mL, even though there was potential for glass contamination.

Passage 4

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

Passage 5

You failed to ensure adequate aseptic behavior and adequate airflow simulations to prevent potential contamination.

Passage 6

Your firm failed to establish adequate written procedures for production and process control designed to assure that drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to follow all of your written production and process control procedures (21 CFR 211.100 (a) and 211.100 (b).