FDA 483 - Zydus Lifesciences Limited - April 23, 2024

This FDA Form 483 document details significant deficiencies observed during an inspection of a pharmaceutical manufacturing facility.

**Facility and Operation Details:** The inspection covers the manufacturing of various Injection products, including those distributed to the US market. Operations involve shared line equipment, aseptic filling, and visual inspection processes.

**Violations and Observations:**

* **Observation 1: Inadequate Investigation of Discrepancies (21 CFR 211.192)** * Failure to thoroughly investigate cross-contamination from inadequate cleaning after Injection batches, leading to rejected batches (OOS/OOT) and the release of other impacted batches to the US market without justification. * Investigations did not assess the release of specific batches when cross-contamination was detected in preceding and subsequent batches, nor did they identify the equipment causing contamination. * Batches filled after a specific date were not evaluated with analytical methods capable of detecting the contaminant, and carryover between same-product batches was not considered. * Investigations into glass particle defects leading to yield deviations or exceeding limits were insufficient, failing to assess all potential sources beyond vial lot-to-lot variation (e.g., product formulation, vial construction, storage). * Batches with similar out-of-limit glass particle defect rates were released to the market, despite a later decision to reject a batch and cease manufacturing due to probable incompatibility between the product and the vial.