# FDA 483 - Ipca Laboratories Limited - June 23, 2023

Source: https://www.globalkeysolutions.net/records/483/ipca-laboratories-limited/aaa284dd-1526-421d-9f3c-6d6d667d6788

> FDA 483 for Ipca Laboratories Limited on June 23, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ipca Laboratories Limited
- Inspection Date: 2023-06-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspection of Ipca Laboratories Limited in Dhar, Madhya Pradesh, revealed critical deficiencies in quality control and manufacturing practices. The firm failed to thoroughly investigate out-of-specification results, lacked established time limits for production phases, and used unverified testing methods. Additionally, issues included poorly maintained equipment, inadequate laboratory controls, non-compliant personnel gowning, and ineffective handling of product complaints, indicating a systemic failure to adhere to cGMP regulations.

## Related Documents

- [483 - 2014-10-17](https://www.globalkeysolutions.net/records/483/ipca-laboratories-limited/6188fd48-4f3d-4aac-a123-f5a2b4dc9baf)
- [483 - 2023-06-23](https://www.globalkeysolutions.net/records/483/ipca-laboratories-limited/fd0e7723-f182-49ba-b84c-9afd34dae565)

## Related Officers

- [Wenzheng Zhang](https://www.globalkeysolutions.net/people/wenzheng-zhang/44b1afce-5ba2-4013-82ac-52c6374c0be4)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)
- [Saleem A. Akhtar](https://www.globalkeysolutions.net/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

Company: https://www.globalkeysolutions.net/companies/ipca-laboratories-limited/8357cd13-53b4-4e4d-a2a5-54b750096c7a

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