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# FDA Hits Lupin’s Novel Labs with 13-item 483
- URL: https://www.fdaweb.com/fda-hits-lupins-novel-labs-with-13-item-483/
- Published: 2022-05-16T12:00:00.000Z
- Updated: 2026-09-14T17:44:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151823

A March FDA inspection of Novel Laboratories (dba Lupin Somerset) has resulted in a 13-item FDA [Form-483](https://www.fda.gov/media/158445/download?ref=fdaweb.com). A 2020 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.

In the latest inspection, FDA cited the firm’s quality system, which it said was a repeat finding, for failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications. It also found the responsibilities and procedures for the quality control unit are not in writing and fully followed. And it said procedures describing the handling of all written and oral complaints regarding a drug product are not written and followed. Other repeat findings include:

- Employees lack the training required to perform their assigned functions.
- Written procedures are not established and followed for the cleaning and maintenance of equipment
- Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
- Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that components conform to appropriate standards.