# FDA 483 - Cipla Ltd. - January 20, 2020

Source: https://www.keypedia.com/records/483/cipla-ltd/188882e0-4d67-4abb-bd52-e0728ee71ad4

> FDA 483 for Cipla Ltd. on January 20, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Cipla Ltd.
- Inspection Date: 2020-01-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Cipla Limited, an API manufacturer in Bangalore, India, from January 20-24, 2020, revealed significant deficiencies in their production and equipment systems. Observations included inadequate process monitoring, insufficient process validation protocols for impurity testing, incomplete batch records, and a lack of proper operational qualification for equipment. These issues indicate a failure to ensure consistent product quality and adherence to manufacturing standards.

## Related Documents

- [483 - 2025-05-26](https://www.keypedia.com/records/483/cipla-ltd/1e5d4e6e-c770-4dc1-bfc6-14c2d583e30c)

## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Teresa I. Navas](https://www.keypedia.com/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)

Company: https://www.keypedia.com/companies/cipla-ltd/d90a952b-3052-4e33-9969-5db3f2bbae82

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1