Tower Laboratories, Ltd.July 30, 2025

FDA 483 - Tower Laboratories, Ltd. - July 30, 2025

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An FDA inspection of Tower Laboratories, Ltd. in Centerbrook, CT, revealed significant deficiencies in manufacturing practices. Observations included inadequate cleaning and maintenance of equipment leading to contamination, failure to follow established laboratory control mechanisms with data integrity concerns, and unsanitary conditions within the manufacturing facility. These issues indicate a lack of adherence to current Good Manufacturing Practices.

Company: Tower Laboratories, Ltd.
Inspection Date: July 30, 2025
Product Type: Drugs
Office: New England District Office
Person: Armen H. Youssoufian

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ID · 8b5b402d-c06d-4b20-89ef-2d2cf8775d52