# FDA 483 - Apothecus Pharmaceutical Corp. - May 17, 2021

Source: https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/0a2b83ac-905b-4038-ab82-eca9e2a0b148

> FDA 483 for Apothecus Pharmaceutical Corp. on May 17, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apothecus Pharmaceutical Corp.
- Inspection Date: 2021-05-17
- Product Type: drugs
- Office Name: Office of Human and Animal Foods Operations - East
- Summary: Apothecus Pharmaceutical Corp. received a Form 483 citing significant deficiencies across multiple areas, including inadequate computer system controls, failure to follow quality unit responsibilities, and insufficient laboratory controls. Repeated observations from a previous inspection highlight persistent issues with data integrity, analytical method validation, and OOS investigations. The firm also demonstrated a lack of employee training, unvalidated process changes, unjustified deviation closures, and poor facility maintenance.

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## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)

Company: https://www.keypedia.com/companies/apothecus-pharmaceutical-corp/d37c243b-2226-4d18-9931-7a3b915e3199

Office: https://www.keypedia.com/offices/office-of-human-and-animal-foods-operations-east/f35344fc-4cf2-4605-b1cf-163d65050588