FDA 483 - Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany - March 20, 2017
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An FDA inspection of Halo Pharmaceutical, Inc. in Whippany, NJ, a drug manufacturer, revealed significant deficiencies across multiple areas of its operations. The firm lacked adequate written procedures for production controls, equipment cleaning, and reprocessing, and failed to thoroughly investigate out-of-specification results. Additionally, the facility's buildings were not maintained in a good state of repair, and raw materials were not stored to prevent contamination.
- Inspection Date
- March 20, 2017
- Product Type
- Drugs
ID · a15123c4-43cf-4ac7-b91b-ae2b1bc3e1de