# FDA 483 - Apothecus Pharmaceutical Corp. - November 15, 2024

Source: https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/417a2316-353c-43b8-84af-0f469a12a511

> FDA 483 for Apothecus Pharmaceutical Corp. on November 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apothecus Pharmaceutical Corp.
- Inspection Date: 2024-11-15
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Apothecus Pharmaceutical Corp. in Hicksville, NY, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate control over labeling, failure to follow written production and process control procedures, and insufficient data integrity controls for laboratory systems. The firm also demonstrated deficiencies in quality control unit procedures, failure to investigate unexplained discrepancies, and non-adherence to product complaint handling procedures.

## Related Documents

- [483 - 2021-05-17](https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/0a2b83ac-905b-4038-ab82-eca9e2a0b148)
- [WARNING_LETTER - 2019-04-30](https://www.keypedia.com/records/warning_letter/apothecus-pharmaceutical-corp/f58b01f8-f932-4fcf-9793-d9612d62a769)
- [483 - 2024-11-15](https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/e0555ff9-efd2-4b56-971c-70a6aae22f49)
- [483 - 2023-10-06](https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/b3c4727c-982c-468d-bd4e-202322f6b38a)
- [483 - 2023-10-06](https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/b2396c30-5a8a-450e-831f-d2b031432b27)

## Related Officers

- [Lundy Abraham](https://www.keypedia.com/people/lundy-abraham/3fbae1a2-1c85-4858-971d-951d74d91f95)
- [Paige R. McCoy](https://www.keypedia.com/people/paige-r-mccoy/d871e1a3-ec99-4c8b-a12f-477d7719f09a)
- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)
- [Heatly H Marlim](https://www.keypedia.com/people/heatly-h-marlim/f3976051-1198-4e1b-8413-beb3c196b15b)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961