# FDA 483 - Cipla Limited - July 19, 2019

Source: https://www.keypedia.com/records/483/cipla-limited/024e48d2-35ef-49f9-ad8b-e77be6e252e9

> FDA 483 for Cipla Limited on July 19, 2019. Product: N/A. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Cipla Limited
- Inspection Date: 2019-07-19
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The FDA Form 483 details significant deficiencies in a facility manufacturing Active Pharmaceutical Ingredients (APIs) and intermediates.

**Facility and Operations:** The inspection revealed issues across quality control, equipment qualification, inventory management, and process/stability validations for API products like (b)(4) USP and (b)(4).

**Violations and Observations:**
*   **Inadequate OOS Investigations:** Investigations into out-of-specification (OOS) QC analytical results for finished API products are insufficient. Root causes for API drug substance failures are not consistently determined. Analytical data assessment is inadequate, failing to evaluate/eliminate all possible OOS sources. Examples include:
    *   **1021_LAB/INV/10/18/05 & 1021_LAB/INV/10/18/02 ((b)(4) Lots (b)(4) and (b)(4)):** OOS for individual impurity during stability testing, attributed to higher temperature/humidity. However, significant main peak shifts in chromatographic data were not evaluated or compared to USP reference standards. Critical (b)(4) step of (b)(4) for key starting material (b)(4) was not controlled/monitored.
    *   **1021_LAB/OOS/02/19/09 ((b)(4) USP Lot (b)(4)):** OOS for description during

## Related Documents

- [483 - 2019-07-19](https://www.keypedia.com/records/483/cipla-limited/3f8bbc67-313f-4442-bdc2-7deda4dfa0a7)
- [483 - 2024-11-13](https://www.keypedia.com/records/483/cipla-limited/53061bbf-ca16-42ce-b780-25e91280d57b)

## Related Officers

- [Christopher S. Keating](https://www.keypedia.com/people/christopher-s-keating/94fcfd32-feb5-4b6c-80da-16202f4be01d)
- [Ralph H. Vocque](https://www.keypedia.com/people/ralph-h-vocque/dfd4e4f2-b03d-44ec-9dd7-7edcee303356)

Company: https://www.keypedia.com/companies/cipla-limited/cefc1473-6852-4af7-b996-0730dc0834bb

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0