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# Lupin Says 13 Observations in Novel Labs Inspection
- URL: https://www.fdaweb.com/lupin-says-13-observations-in-novel-labs-inspection/
- Published: 2022-03-31T12:00:00.000Z
- Updated: 2026-09-14T17:38:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151500

Lupin Pharmaceuticals, a manufacturer of branded and generic drugs, says FDA completed 3/30 an inspection at its Novel Laboratories wholly-owned subsidiary in Somerset, NJ, with 13 observations. “We are confident of addressing these observations and will work closely with the agency to address their concerns,” the company says in a [statement](https://equitybulls.com/category.php?id=310278&ref=fdaweb.com). A 9/10-11/5/20 agency inspection at the Novel facility led to a 6/11/21 [Warning Letter](https://www.fdaweb.com/cgmp-violations-at-lupin-new-jersey-plant/) citing three significant violations of current good manufacturing practice regulations for finished drugs.