# FDA 483 - Cipla Limited - June 21, 2024

Source: https://www.keypedia.com/records/483/cipla-limited/6e6db655-6ac9-49bd-9d30-2442d2bf857f

> FDA 483 for Cipla Limited on June 21, 2024. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cipla Limited
- Inspection Date: 2024-06-21
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in quality control and manufacturing processes.

**Facility and Operations:** The inspection covered a facility manufacturing commercial drug products and active pharmaceutical ingredients (APIs) for the US market, including sterile products from a Unit Line.

**Violations and Observations:**

*   **Test Method Validation:** Accuracy, sensitivity, specificity, and reproducibility of test methods for commercial drug products (both approved and distributed, and approved but not yet commercial), APIs, and in-process tests were not established or documented. This violates the firm's SOP 1035-L-0016.
*   **Environmental Monitoring (EM) Deficiencies:**
    *   Viable surface monitoring in critical Grade A areas of the Unit Line did not ensure microbial contamination recognition.
    *   EM sampling was random, lacking a systematic plan for uniform and representative coverage. Specific examples of infrequent sampling for Lines #13, #1, and #54 were cited.
    *   Swab validation for Grade A viable surface monitoring failed to establish a limit of detection for "no growth" results, despite the Grade A action limit being 0 cfu. A vendor's validation showed no growth after inoculating with 1 cfu and 2 cfu S. aureus, failing to assure 0 cfu for "no growth" results.
    *   Swab validation did not include testing

## Related Documents

- [483 - 2016-08-30](https://www.keypedia.com/records/483/cipla-limited/72b519eb-58af-4d80-991a-d0eb593f645f)
- [483 - 2019-09-27](https://www.keypedia.com/records/483/cipla-limited/df1fd743-d55e-4cd8-aa93-f66bb318c12d)
- [483 - 2019-01-28](https://www.keypedia.com/records/483/cipla-limited/96151c31-a5c8-4cfa-b564-ee38cfa14dad)
- [483 - 2022-08-26](https://www.keypedia.com/records/483/cipla-limited/3c4414ab-af3a-425d-bb60-2b91ddd03159)
- [483 - 2024-06-21](https://www.keypedia.com/records/483/cipla-limited/8db1e1bc-0bc5-4334-9558-e7aa003c3b7d)

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

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