Torbay Pharmaceuticals Ltd.November 12, 2024

FDA 483 - Torbay Pharmaceuticals Ltd. - November 12, 2024

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Record Details

Torbay Pharmaceuticals, Ltd. in Paignton, UK, was inspected and received a Form FDA 483 with four observations related to significant deficiencies in their drug manufacturing processes. The firm failed to thoroughly investigate product discrepancies, lacked adequate quality unit oversight and documentation control, exhibited poor equipment cleaning and maintenance, and had an inadequate environmental monitoring system for aseptic processing areas.

Company: Torbay Pharmaceuticals Ltd.
Inspection Date: November 12, 2024
Product Type: Drugs
Office: Office of Inspections and Investigations
People: Jose E. Melendez (Quality System Specialist)
Damaris Y. Hernandez

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ID · 1895b4ec-d145-4428-a517-ab5060ba1a81