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483
•King Pharmaceuticals LLC•October 21, 2019

King Pharmaceuticals LLC – FDA 483, Oct 21, 2019

Record Details

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.

Company
King Pharmaceuticals LLC
Inspection date
October 21, 2019
Product type
drugs
Office
Division of Pharmaceutical Quality Operations III
People
  • Alan M. Roberts
  • Jeffrey D. Meng (Associate Director)
  • Jacob G. Lutz (Investigator)
View Company Profile

ID · 589209b1-870a-4c6a-8718-de4e70e013db

Other documents for King Pharmaceuticals LLC
  • 483 - 2025-02-18February 18, 2025

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