# FDA 483 - Ipca Laboratories Limited - August 23, 2019

Source: https://www.globalkeysolutions.net/records/483/ipca-laboratories-limited/bc8f4a18-427f-4e23-8106-ac7d740888c5

> FDA 483 for Ipca Laboratories Limited on August 23, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ipca Laboratories Limited
- Inspection Date: 2019-08-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspection of Ipca Laboratories Limited in Silvasa, India, revealed significant deficiencies in the firm's Quality Unit and adherence to current Good Manufacturing Practices (cGMP). Key issues included inadequate investigation of unknown peaks in laboratory tests, deviations from standard operating procedures, and an incomplete electronic data assessment that compromised data integrity. The firm also failed to thoroughly investigate out-of-specification and out-of-trend results, and exhibited systemic delays in closing product complaints, change controls, and CAPAs, indicating a severe breakdown in quality management.

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## Related Officers

- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

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

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