# Cipla Limited – FDA 483, Aug 25, 2026

Source: https://www.keypedia.com/records/483/cipla-limited/a0856369-8345-48b9-a3e3-cb2657ac1116

> FDA 483 for Cipla Limited on August 25, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cipla Limited
- Inspection Date: 2026-08-25
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Cipla Limited, a sterile and non-sterile drug manufacturer in Pithampur, India, was cited with seven observations during an FDA inspection. The inspection revealed significant deficiencies in complaint handling, aseptic processing controls, environmental monitoring, investigation of discrepancies, computer system controls, manufacturing process validation, and equipment cleaning procedures. These issues indicate a high risk of product contamination and quality control failures.

## Related Documents

- [WARNING_LETTER - 2023-02-17](https://www.keypedia.com/records/warning_letter/cipla-limited/4a179ebd-255d-4805-a6d2-4e500633be4e) — date: February 17, 2023
- [483 - 2023-02-17](https://www.keypedia.com/records/483/cipla-limited/0c4d85ed-d21a-4440-8835-7e2f111667e9) — date: February 17, 2023
- [483 - 2022-07-01](https://www.keypedia.com/records/483/cipla-limited/606c0e82-5b62-4d28-bbe3-aa7eac7ea30d) — date: July 1, 2022
- [WARNING_LETTER - 2019-09-27](https://www.keypedia.com/records/warning_letter/cipla-limited/6321f828-da26-4571-b32c-638dd2cf14df) — date: September 27, 2019
- [483 - 2018-04-13](https://www.keypedia.com/records/483/cipla-limited/c8ec2a41-eca9-41c6-8e7d-d507b965a6dc) — date: April 13, 2018

## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Xiaokuang Lai](https://www.keypedia.com/people/xiaokuang-lai/6c25851d-0954-4f42-8f14-c2e0382e6815)

Company: https://www.keypedia.com/companies/cipla-limited/de9dc5de-fbea-4a7d-ab5b-a398b6ed442e

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3