# FDA 483 - Cipla Limited - August 30, 2016

Source: https://www.keypedia.com/records/483/cipla-limited/72b519eb-58af-4d80-991a-d0eb593f645f

> FDA 483 for Cipla Limited on August 30, 2016. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cipla Limited
- Inspection Date: 2016-08-30
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: This FDA Form 483 document outlines observations made during an inspection, indicating several deficiencies in the facility's operations and quality systems.

**Facility and Operation Details:** The document does not specify the name or location of the facility, nor the exact type of drug product manufactured, beyond mentioning "drug products purporting to be sterile" and "distributed drug product."

**Violations and Observations:**
1.  **Inadequate Investigations:** Investigations into unexplained discrepancies or batch failures (where a batch or its components failed to meet specifications) did not extend to other batches of the same drug product. This suggests a limited scope of root cause analysis.
2.  **Microbiological Contamination Control:** Procedures intended to prevent microbiological contamination of sterile drug products were either not written or not followed. This is a critical observation for sterile manufacturing, directly impacting product safety and efficacy.
3.  **Equipment Design:** Equipment used in manufacturing, processing, packing, or holding drug products was not of appropriate design to facilitate its intended use. This could lead to operational inefficiencies, contamination risks, or product quality issues.
4.  **Failure to Submit Field Alert Report (FAR):** A Field Alert Report was not submitted within three working days of receiving information about a significant chemical, physical, or other change or deterioration in a distributed drug product. This indicates a failure to comply with regulatory reporting requirements for potential product quality issues in the market.

**Regulatory Citations and Requirements:** The observations implicitly cite

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## Related Officers

- [Director, Enterprise Regulatory Compliance](https://www.keypedia.com/people/nicholas-a-violand/c0c3ee7a-8adb-43d2-974c-06220ef8e8eb)

Company: https://www.keypedia.com/companies/cipla-limited/6b5864ed-07a2-4861-b424-021018d4f7e9

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe