# Apothecus Pharmaceutical Corp. – FDA 483, Oct 6, 2023

Source: https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/b3c4727c-982c-468d-bd4e-202322f6b38a

> FDA 483 for Apothecus Pharmaceutical Corp. on October 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apothecus Pharmaceutical Corp.
- Inspection Date: 2023-10-06
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Apothecus Pharmaceutical Corp. in Hicksville, NY, was cited for significant deficiencies in its manufacturing operations for VCF Contraceptive Film and Gel. The inspection revealed critical failures in out-of-specification investigations, component testing, quality unit oversight, process validation, labeling control, and change control procedures, indicating a systemic lack of adherence to cGMP regulations. These issues raise concerns about the identity, strength, purity, and quality of distributed drug products.

## Related Documents

- [483 - 2024-11-15](https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/e0555ff9-efd2-4b56-971c-70a6aae22f49) — date: November 15, 2024
- [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

- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)
- [Daniel B. Sweitzer](https://www.keypedia.com/people/daniel-b-sweitzer/0a03cb75-dca0-4bcc-a94f-b1db1893c240)
- [Drug Discovery and Biotech Executive](https://www.keypedia.com/people/lloyd-d-payne/8b98c38a-4fbe-465d-bb0a-689bcc6db702)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94