# FDA 483 - Ipca Laboratories Limited - October 17, 2014

Source: https://www.globalkeysolutions.net/records/483/ipca-laboratories-limited/6188fd48-4f3d-4aac-a123-f5a2b4dc9baf

> FDA 483 for Ipca Laboratories Limited on October 17, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ipca Laboratories Limited
- Inspection Date: 2014-10-17
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Ipca Laboratories Ltd in Pithampur, India, revealed significant data integrity and quality control deficiencies. The firm was observed performing unreported "trial" injections to achieve passing results, deleting and overwriting raw electronic data, and lacking proper computer system controls. Additionally, the inspection found inadequate deviation investigations, uncontrolled quality unit stamps, and failures in employee training documentation.

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## Related Officers

- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)
- [President](https://www.globalkeysolutions.net/people/peter-e-baker/c32eb848-de28-4725-80c9-ef8548d445bf)

Company: https://www.globalkeysolutions.net/companies/ipca-laboratories-limited/8357cd13-53b4-4e4d-a2a5-54b750096c7a

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