# FDA 483 - Apothecus Pharmaceutical Corp. - April 30, 2019

Source: https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/05682ae1-19d7-41c4-9b11-e5891b1b8439

> FDA 483 for Apothecus Pharmaceutical Corp. on April 30, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apothecus Pharmaceutical Corp.
- Inspection Date: 2019-04-30
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Apothecus Pharmaceutical Corp. in Hicksville, NY, a pharmaceutical drug manufacturer, was cited for multiple significant deficiencies in its quality control and manufacturing processes. Key issues include inadequate testing and method validation for contraceptive products, insufficient out-of-specification investigations, and a lack of equipment cleaning validation. Additionally, the firm demonstrated personnel shortages leading to testing backlogs, poor computer system controls, and inadequate temperature monitoring for drug storage, indicating a systemic lack of adherence to GMP requirements.

## Related Documents

- [483 - 2024-11-15](https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/417a2316-353c-43b8-84af-0f469a12a511)
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- [WARNING_LETTER - 2019-04-30](https://www.keypedia.com/records/warning_letter/apothecus-pharmaceutical-corp/f58b01f8-f932-4fcf-9793-d9612d62a769)
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- [483 - 2023-10-06](https://www.keypedia.com/records/483/apothecus-pharmaceutical-corp/b3c4727c-982c-468d-bd4e-202322f6b38a)

## Related Officers

- [Consumer Safety Officer Drug Specialist](https://www.keypedia.com/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)
- [Investigator](https://www.keypedia.com/people/meredith-p-soehl/52252b59-8f03-41e4-a86f-b92c98048023)

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