# FDA 483 - Ipca Laboratories Limited - April 26, 2023

Source: https://www.keypedia.com/records/483/ipca-laboratories-limited/f02c8bd8-643e-46b9-b877-77c6573c8792

> FDA 483 for Ipca Laboratories Limited on April 26, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ipca Laboratories Limited
- Inspection Date: 2023-04-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Ipca Laboratories Ltd. in Piparia, Silvassa, India, was cited for significant deficiencies in its quality control unit and laboratory operations during an FDA inspection. The firm failed to adequately investigate out-of-specification and out-of-trend results, often invalidating them without scientific justification, and demonstrated a lack of data integrity across various systems and documentation practices. Additionally, deviation investigations and corrective actions were found to be untimely, inaccurate, and ineffective.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/ipca-laboratories-limited/e14ab878-c476-4020-b629-c54df1898d84)
- [483 - 2019-08-23](https://www.keypedia.com/records/483/ipca-laboratories-limited/bc8f4a18-427f-4e23-8106-ac7d740888c5)
- [483 - 2019-08-23](https://www.keypedia.com/records/483/ipca-laboratories-limited/a6e68501-3e7a-4f80-9c56-1e2c02f3b7df)
- [483 - 2023-04-26](https://www.keypedia.com/records/483/ipca-laboratories-limited/51a2952b-2caf-441c-951c-c2b057b2605b)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)
- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.keypedia.com/companies/ipca-laboratories-limited/4221e8f5-a261-45fc-b9fc-d935bc1f225b

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