483
Halo Pharmaceutical, Inc. d/b/a Cambrex WhippanyHalo Pharmaceutical, Inc. d/b/a Cambrex Whippany – FDA 483, Feb 17, 2023
Record Details
An FDA inspection of Halo Pharmaceutical, Inc. d/b/a Cambrex in Whippany, NJ, from February 7-17, 2023, identified a significant issue with equipment qualification. The firm was cited for using production equipment in commercial manufacturing that was not appropriately qualified for its intended use. This indicates a critical lapse in ensuring manufacturing equipment meets regulatory standards.
- Inspection date
- February 17, 2023
- Product type
- drugs
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ID · 85c16a13-185e-4160-8506-5e5d9a880e64
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