# FDA 483 - King Pharmaceuticals LLC - February 18, 2025

Source: https://www.keypedia.com/records/483/king-pharmaceuticals-llc/0b1a81a9-74c5-4125-9ef6-34fc1bcd7429

> FDA 483 for King Pharmaceuticals LLC on February 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: King Pharmaceuticals LLC
- Inspection Date: 2025-02-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: King Pharmaceuticals LLC in Rochester, MI, was cited with four observations during an FDA inspection from February 10-18, 2025, for significant deficiencies in sterile drug manufacturing. The observations highlight issues with aseptic processing controls, visual inspection methods for particulates, the authority of the quality control unit, and the thoroughness of investigations into foreign material contamination. These findings indicate a need for improved quality systems to ensure drug product sterility and quality.

## Related Documents

- [483 - 2019-10-21](https://www.keypedia.com/records/483/king-pharmaceuticals-llc/589209b1-870a-4c6a-8718-de4e70e013db)
- [483 - 2025-02-18](https://www.keypedia.com/records/483/king-pharmaceuticals-llc/9e7a48a4-3559-425d-9cad-9d60f62c3a43)

## Related Officers

- [Joohi Castelvetere](https://www.keypedia.com/people/joohi-castelvetere/2340bef8-5105-4f40-9713-120196b70d82)
- [Nicholas J. Presto](https://www.keypedia.com/people/nicholas-j-presto/2ecdd573-6662-4d07-b93c-ddb9c603bcfa)
- [Investigator](https://www.keypedia.com/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

Company: https://www.keypedia.com/companies/king-pharmaceuticals-llc/d90c79dd-4325-4185-bf42-87c7f116f6c5

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0