> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CGMP Violations in Noven Inspection
- URL: https://www.fdaweb.com/cgmp-violations-in-noven-inspection/
- Published: 2016-08-16T12:00:00.000Z
- Updated: 2026-09-14T21:24:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136516

A 6/22-7/10 FDA inspection at Noven Pharmaceuticals, Miami, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 8/5 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516222.htm?ref=fdaweb.com) from the agency’s Florida District Office. Specific violations included: 

- failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods;
- failing to record and justify any deviations from required laboratory control mechanisms;
- failing to thoroughly investigate any unexplained discrepancy of failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
- failing to maintain written records so that data in them could be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures; and
- failing to follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product including provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation.

The company’s responses to the inspection observations were inadequate. Noven was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence. FDA recommended that the firm engage a qualified consultant to assist it in meeting CGMP requirements.