# FDA 483 - Apotex Research Private Limited - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/apotex-research-private-limited/e4899c56-8df1-4d9f-8486-9e68edd1627b

> FDA 483 for Apotex Research Private Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apotex Research Private Limited
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Apotex Research Private Limited in Bangalore, India, revealed significant deficiencies in manufacturing process validation, laboratory controls, and quality unit procedures. The firm failed to thoroughly investigate discrepancies, maintain equipment, and ensure proper documentation and tracking of materials and samples. Repeat observations were noted regarding control procedures and the stability testing program, indicating systemic issues.

## Related Documents

- [WARNING_LETTER - 2014-07-01](https://www.globalkeysolutions.net/records/warning_letter/apotex-research-private-limited/c495a8cb-2d48-4dc3-87b9-48e3e60b41f8)

## Related Officers

- [Aditi S. Thakur](https://www.globalkeysolutions.net/people/aditi-s-thakur/1c810eb2-86b0-4cae-b51d-43f3fb276ade)
- [Rebecca E. Dombrowski](https://www.globalkeysolutions.net/people/rebecca-e-dombrowski/2979b9b1-d067-4165-a5c2-5f0b94dd4eaf)
- [Sandra A. Hughes](https://www.globalkeysolutions.net/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

Company: https://www.globalkeysolutions.net/companies/apotex-research-private-limited/074db0b0-4f5f-4ee7-90e9-1c661c86f90c

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