# FDA 483 - King Pharmaceuticals LLC - October 21, 2019

Source: https://www.keypedia.com/records/483/king-pharmaceuticals-llc/589209b1-870a-4c6a-8718-de4e70e013db

> FDA 483 for King Pharmaceuticals LLC on October 21, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: King Pharmaceuticals LLC
- Inspection Date: 2019-10-21
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Kind Pharmaceuticals, LLC. in Rochester, MI, was inspected and cited for a single observation related to its quality control unit. The firm failed to fully follow its own procedures for cleaning validation, specifically by not applying required correction factors from swab recovery studies during re-qualification. This indicates a deficiency in adhering to established quality control processes.

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## Related Officers

- [Associate Director](https://www.keypedia.com/people/jeffrey-d-meng/55543677-bd74-4cc5-8a2a-e14afb91d338)
- [Alan M. Roberts](https://www.keypedia.com/people/alan-m-roberts/b6565c30-6228-4f51-a1b7-369bffe54e9c)
- [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