# FDA 483 - Ipca Laboratories Limited - Unknown Date

Source: https://www.keypedia.com/records/483/ipca-laboratories-limited/e14ab878-c476-4020-b629-c54df1898d84

> FDA 483 for Ipca Laboratories Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ipca Laboratories Limited
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Ipca Laboratories Ltd. in Piparia, Silvassa, India, a drug product manufacturer, was cited for multiple quality control deficiencies during an FDA inspection. Observations included failures to follow chromatography procedures, scientifically unsound microbiological media growth promotion tests, inadequate filter integrity testing, and insufficient checkweigher functionality testing. These issues indicate significant concerns regarding data integrity, quality control, and adherence to established procedures.

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## Related Officers

- [investigator](https://www.keypedia.com/people/parul-m-patel/2a7e7ff1-6b9b-42d7-8bc4-03eeecc5cecc)
- [investigator](https://www.keypedia.com/people/james-c-maclaughlin/b4a44fd7-c09a-4f4c-bc39-5c254dfa468c)

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

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321