# FDA 483 - Cadila Pharmaceuticals Limited - May 10, 2024

Source: https://www.globalkeysolutions.net/records/483/cadila-pharmaceuticals-limited/7f625ff3-ac7f-4626-bb20-df3fe1487e26

> FDA 483 for Cadila Pharmaceuticals Limited on May 10, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Cadila Pharmaceuticals Limited
- Inspection Date: 2024-05-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Cadila Pharmaceuticals Limited, an API drug manufacturer in Ankleshwar, India, was cited for significant deficiencies across laboratory controls, manufacturing equipment validation, and quality control documentation. Issues included inadequate water system monitoring for microbial contamination, unvalidated equipment usage, and a lack of written procedures for document disposal. These findings indicate a moderate level of severity regarding quality system compliance.

## Related Officers

- [Alan A. Rivera](https://www.globalkeysolutions.net/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)
- [Angelica M. Hernandez](https://www.globalkeysolutions.net/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.globalkeysolutions.net/companies/cadila-pharmaceuticals-limited/042118cf-4e9b-432b-b155-94c2b5e3e025

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