# Apothecus Pharmaceutical Corp. – FDA 483, Nov 15, 2024

Source: https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/e0555ff9-efd2-4b56-971c-70a6aae22f49

> 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: New York District Office
- Summary: Apothecus Pharmaceutical Corp. in Hicksville, NY, a non-sterile human drug manufacturer, was cited for multiple significant deficiencies during an FDA inspection. The observations primarily concern inadequate controls over labeling, failure to follow written production procedures, poor data integrity practices for computer systems, and deficiencies in quality control unit procedures, discrepancy investigations, and product complaint handling. These issues indicate a systemic lack of adherence to cGMP requirements.

## Related Documents

- [483 - 2023-10-06](https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/b3c4727c-982c-468d-bd4e-202322f6b38a) — date: October 6, 2023
- [483 - 2021-05-17](https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/599820a6-6a36-4ef4-bcf6-21f29ec9be94) — date: May 17, 2021
- [WARNING_LETTER - 2019-04-30](https://www.keypedia.com/records/warning_letter/apothecus-pharmaceutical-corp/f58b01f8-f932-4fcf-9793-d9612d62a769) — date: April 30, 2019
- [483 - 2019-04-30](https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/05682ae1-19d7-41c4-9b11-e5891b1b8439) — date: April 30, 2019

## Related Officers

- [Lundy Abraham](https://www.keypedia.com/people/lundy-abraham/3fbae1a2-1c85-4858-971d-951d74d91f95)
- [Austin H Marlin](https://www.keypedia.com/people/austin-h-marlin/6f65ed9f-3d79-41db-a067-3c0e760e2ad7)
- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)
- [Paige R. McCoy](https://www.keypedia.com/people/paige-r-mccoy/d871e1a3-ec99-4c8b-a12f-477d7719f09a)
- [Luxuly Abraham](https://www.keypedia.com/people/luxuly-abraham/d33e3164-ec89-488b-bab9-a9ec30544970)

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

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d