# FDA 483 - Cipla Limited - June 21, 2024

Source: https://www.globalkeysolutions.net/records/483/cipla-limited/8db1e1bc-0bc5-4334-9558-e7aa003c3b7d

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

---

## Details

- Record Type: 483
- Company Name: Cipla Limited
- Inspection Date: 2024-06-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Cipla Limited, a drug manufacturer in Verna, India, received a Form 483 with six observations during an FDA inspection from June 10-21, 2024. The observations highlight significant deficiencies in test method validation, environmental monitoring for aseptic processing, cleaning and disinfection procedures, and investigation of batch failures. Additionally, issues were noted with computer system access controls and adherence to quality control unit procedures.

## Related Documents

- [483 - 2016-08-30](https://www.globalkeysolutions.net/records/483/cipla-limited/72b519eb-58af-4d80-991a-d0eb593f645f)
- [483 - 2019-09-27](https://www.globalkeysolutions.net/records/483/cipla-limited/df1fd743-d55e-4cd8-aa93-f66bb318c12d)
- [483 - 2022-08-26](https://www.globalkeysolutions.net/records/483/cipla-limited/3c4414ab-af3a-425d-bb60-2b91ddd03159)
- [483 - 2019-01-28](https://www.globalkeysolutions.net/records/483/cipla-limited/96151c31-a5c8-4cfa-b564-ee38cfa14dad)
- [483 - 2018-01-25](https://www.globalkeysolutions.net/records/483/cipla-limited/00e64667-a769-4e4b-bbed-c435ef1a7485)

## Related Officers

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

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

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