# FDA 483 - Apotex Research Private Limited - March 15, 2024

Source: https://www.keypedia.com/records/483/apotex-research-private-limited/ff53473b-8a4e-4ca7-a6a0-fc07672a264a

> FDA 483 for Apotex Research Private Limited on March 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apotex Research Private Limited
- Inspection Date: 2024-03-15
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Apotex Research Private Limited in Bangalore, India, received a Form 483 during an FDA inspection from March 11-15, 2024. The firm was cited for failing to adequately investigate unexplained discrepancies and anomalous results, and for not establishing written procedures for production and process controls. Additionally, the quality control unit's responsibilities and procedures were not fully followed, indicating significant deficiencies in their quality system.

## Related Documents

- [WARNING_LETTER - 2014-07-01](https://www.keypedia.com/records/warning_letter/apotex-research-private-limited/c495a8cb-2d48-4dc3-87b9-48e3e60b41f8)
- [483 - Unknown Date](https://www.keypedia.com/records/483/apotex-research-private-limited/e4899c56-8df1-4d9f-8486-9e68edd1627b)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Aditi Thakur](https://www.keypedia.com/people/aditi-thakur/d98b0325-ab10-44f6-924f-43049d7fc3ec)

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

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3