# FDA 483 - Zydus Lifesciences Limited - April 23, 2024

Source: https://www.keypedia.com/records/483/zydus-lifesciences-limited/acababa6-4afe-4094-9f57-2fd616abbaf0

> FDA 483 for Zydus Lifesciences Limited on April 23, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zydus Lifesciences Limited
- Inspection Date: 2024-04-23
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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.

## Related Documents

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## Related Officers

- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/zydus-lifesciences-limited/b4ab6750-9275-47bd-a575-c425b82b300d

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c