# FDA 483 - Apothecon Pharmaceuticals Private Limited - January 27, 2023

Source: https://www.keypedia.com/records/483/apothecon-pharmaceuticals-private-limited/1ebb2750-95a4-453c-87de-3516afdb1d92

> FDA 483 for Apothecon Pharmaceuticals Private Limited on January 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apothecon Pharmaceuticals Private Limited
- Inspection Date: 2023-01-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Apothecon Pharmaceuticals Private Limited in Vadodara, India, was cited for significant deficiencies across its laboratory, quality, material, and facilities systems during an FDA inspection. Observations included failures in OOS investigations and data reporting, inadequate test method validation, and insufficient laboratory controls. The firm also failed to properly manage returned drug products and ensure continuous temperature monitoring for critical storage equipment.

## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
- [Consumer Safety Officer (Drug Specialist)](https://www.keypedia.com/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

Company: https://www.keypedia.com/companies/apothecon-pharmaceuticals-private-limited/9fd69fd5-d0ef-458e-bdf3-b9b73b75f954

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1