# FDA 483 - Pharmaceutics International, Inc. - April 04, 2016

Source: https://www.keypedia.com/records/483/pharmaceutics-international-inc/6fb09bb0-c571-4f95-9373-92e75ada3ab8

> FDA 483 for Pharmaceutics International, Inc. on April 04, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutics International, Inc.
- Inspection Date: 2016-04-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Pharmaceutics International, Inc. in Cockeysville, MD, was cited for multiple significant deficiencies during an FDA inspection from March 21 to April 4, 2016, primarily concerning sterile drug product manufacturing. Observations included failures in preventing microbiological contamination, inadequate equipment cleaning and maintenance, insufficient laboratory controls, and poor quality system adherence. These issues indicate a broad lack of adherence to cGMPs, posing potential risks to drug product quality and patient safety.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/toyin-b-oladimeji/0aff4ab4-a1ff-4394-a32d-747bdc5f248b)
- [investigator](https://www.keypedia.com/people/eric-dong/762c3fe2-593d-41b6-8903-7c354f732435)
- [Drug Investigator](https://www.keypedia.com/people/deyaa-shaheen/ebbabce5-347c-4de4-abed-ba9da11c26ed)

Company: https://www.keypedia.com/companies/pharmaceutics-international-inc/38fdf7bd-a7f3-486e-b74d-13b87414922e

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e