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483
•Medique Products•July 18, 2024

Medique Products – FDA 483, Jul 18, 2024

Record Details

UniFirst First Aid + Safety in Fort Myers, FL, was inspected from July 16-18, 2024, and received a Form 483. The inspection revealed significant deficiencies in the firm's quality control unit, specifically concerning the inspection and release of incoming finished OTC drug products, the receipt of Certificates of Analysis, and the retention of product samples. These issues indicate a failure to follow established procedures for ensuring product quality and compliance.

Company
Medique Products
Inspection date
July 18, 2024
Product type
drugs
Office
Office of Medical Device and Radiological Health Division II
People
  • Rodney L. Tinzie
  • Kayla V. Sprague (Pharmaceutical Investigator)
View Company Profile

ID · 5c337bed-ea73-4608-8e92-04a350144025

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