# FDA 483 - Ipca Laboratories Limited - July 14, 2014

Source: https://www.keypedia.com/records/483/ipca-laboratories-limited/d8a74e62-ce0e-4409-9569-75fdfaa44bce

> FDA 483 for Ipca Laboratories Limited on July 14, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ipca Laboratories Limited
- Inspection Date: 2014-07-14
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: The FDA inspection of IPCA Laboratories, Ltd. in Ratlam, India, revealed severe data integrity issues within their QC Analytical and Microbiology laboratories, including manipulation of test results, back-dating of records, and falsification of samples. The firm also failed to adequately train personnel, maintain stable incubation conditions, properly evaluate reprocessing of non-conforming batches, and assess critical production deviations. These findings indicate significant deficiencies in the firm's quality control and manufacturing practices.

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## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)
- [President](https://www.keypedia.com/people/peter-e-baker/c32eb848-de28-4725-80c9-ef8548d445bf)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd