# FDA 483 - Apotex Pharmachem India Pvt Ltd. - March 14, 2025

Source: https://www.keypedia.com/records/483/apotex-pharmachem-india-pvt-ltd/15522102-06ff-469b-9f4f-2f7ac42f712a

> FDA 483 for Apotex Pharmachem India Pvt Ltd. on March 14, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Apotex Pharmachem India Pvt Ltd.
- Inspection Date: 2025-03-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Apotex Pharmachem India Pvt Ltd. in Bangalore was cited for significant deficiencies across its quality, production, facilities, and laboratory control systems. The inspection revealed failures in investigating out-of-specification results, inadequate cleaning and shipping validations, deficient master production records, and poor equipment maintenance and laboratory controls. These issues indicate a systemic lack of adherence to established procedures and scientific rationale, impacting the quality and purity of US-marketed APIs.

## Related Documents

- [WARNING_LETTER - 2014-01-31](https://www.keypedia.com/records/warning_letter/apotex-pharmachem-india-pvt-ltd/90b86d10-5127-492c-90c6-9aadfbe79680)

## Related Officers

- [Yvins Dezan](https://www.keypedia.com/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.keypedia.com/companies/apotex-pharmachem-india-pvt-ltd/8aa6fc29-dc9f-4154-90af-d0bf193414c5

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8