The W.S. Badger Company, Inc.September 14, 2021

FDA 483 - The W.S. Badger Company, Inc. - September 14, 2021

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Record Details

The W.S. Badger Company, Inc. in Gilsum, NH, was inspected regarding its manufacturing of OTC drug products. The inspection revealed significant deficiencies in process validation, quality control unit oversight, investigation of discrepancies, equipment cleaning validation, stability programs, and annual product reviews. Several observations were repeats from a previous inspection, indicating persistent issues with quality systems and compliance.

Company: The W.S. Badger Company, Inc.
Inspection Date: September 14, 2021
Product Type: Drugs
Office: Division of Northeast Imports
People: Lauren N. Barber (investigator)
David A. Oluwo (Pharmacy Intern/Certified Pharmacy Technician)

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ID · 4ec86001-742d-4c3f-a3f4-ab3eb9b10483