# FDA 483 - Chartwell Pharmaceuticals Amityville, LLC - February 13, 2019

Source: https://www.keypedia.com/records/483/chartwell-pharmaceuticals-amityville-llc/d1cdf69f-9f0a-4fe6-94a0-1cbc864a8338

> FDA 483 for Chartwell Pharmaceuticals Amityville, LLC on February 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chartwell Pharmaceuticals Amityville, LLC
- Inspection Date: 2019-02-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Hi-Tech Pharmacal Co. Inc., an AKORN Company, in Amityville, NY, revealed significant deficiencies in their sterile and non-sterile drug manufacturing operations. Observations included inadequate equipment maintenance records, improper aseptic processing practices, failure to follow the written stability testing program, and insufficient testing of containers and closures. These issues led to numerous customer complaints regarding product quality.

## Related Documents

- [483 - 2022-12-21](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-amityville-llc/726e0109-e40e-42ce-8c36-e43dd6c5ef08)

## Related Officers

- [investigator](https://www.keypedia.com/people/jay-wong/d58065c6-6c52-4d77-af6b-089176c778c9)

Company: https://www.keypedia.com/companies/chartwell-pharmaceuticals-amityville-llc/d8360380-d99c-4c6b-a098-04d0bcc0f7c1

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