483
Novel Laboratories, Inc. d.b.a Lupin SomersetNovel Laboratories, Inc. d.b.a Lupin Somerset – FDA 483, Jan 13, 2023
Record Details
Novel Laboratories, Inc. d.b.a Lupin in Somerset, NJ, was inspected and received two observations related to manufacturing practices. The inspection revealed deficiencies in laboratory controls, specifically regarding the scientific justification for microbial testing procedures, and issues with equipment qualification and design for its intended use in drug product manufacturing. These findings indicate potential risks to drug product quality and purity.
- Inspection date
- January 13, 2023
- Product type
- drugs
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ID · 2dd544ba-ef47-4a02-8afc-afbe901915b8
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