# FDA 483 - Ipca Laboratories Limited - June 13, 2023

Source: https://www.keypedia.com/records/483/ipca-laboratories-limited/54b248f6-2ba4-41ee-ba17-48b893118f0e

> FDA 483 for Ipca Laboratories Limited on June 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ipca Laboratories Limited
- Inspection Date: 2023-06-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Ipca Laboratories Ltd. received a Form 483 citing significant deficiencies in their API manufacturing operations. Observations included inadequate investigations into OOS results, deviations, and market complaints, as well as failures by the Quality Unit to take appropriate actions for failing API batches. The firm also lacked scientifically sound procedures for process validation, analytical testing, and equipment cleaning, alongside issues with batch certification and record keeping.

## Related Documents

- [483 - 2014-07-14](https://www.keypedia.com/records/483/ipca-laboratories-limited/d8a74e62-ce0e-4409-9569-75fdfaa44bce)
- [483 - 2023-06-13](https://www.keypedia.com/records/483/ipca-laboratories-limited/71d37b52-32ac-4870-83d4-01589e15d2fb)

## Related Officers

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

Company: https://www.keypedia.com/companies/ipca-laboratories-limited/693249b7-900f-4dae-93ff-945b0dcce8d6

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