# FDA 483 - Apothecus Pharmaceutical Corp. - October 06, 2023

Source: https://www.globalkeysolutions.net/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: FDA District Office — Stoneham, Massachusetts
- 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.

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## Related Officers

- [M.S., Consumer Safety Officer at FDA](https://www.globalkeysolutions.net/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7