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# CGMP Violations in 2 Unimark Facilities
- URL: https://www.fdaweb.com/cgmp-violations-in-2-unimark-facilities/
- Published: 2016-08-23T12:00:00.000Z
- Updated: 2026-09-14T21:26:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136579

FDA inspections at Unimark Remedies’ active pharmaceutical ingredient Vapi facility (5/18-5/22/15) and Belva facility (8/3-8/14/15), both in India, found significant deviations from current good manufacturing practice regulations, according to an 8/15 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516883.htm?ref=fdaweb.com). Specific violations found at the Vapi facility included: 

- failing to adequately investigate and document out-of-specification results and to implement appropriate corrective actions; and
- failing to evaluate the potential effect that changes in the manufacturing process may have on the quality of the firm’s active pharmaceutical ingredients.

 Specific violations at the Belva facility included: 

- failing to adequately investigate and document out-of-specification results and to implement appropriate corrective actions;
- failing to ensure that test procedures are scientifically sound and appropriate to ensure that the active pharmaceutical ingredients conform to established standards of quality and/or purity;
- failing to maintain training records of employees involved in the manufacture of intermediates or active pharmaceutical ingredients; and
- failing to properly keep buildings and facilities used in the manufacture of active pharmaceutical ingredients in a clean condition.

The company was told to respond with a list of the actions it took since the inspection to correct the deviations and prevent their recurrence, along with a timetable for completion.

At least eight other Warning Letters have been issued to firms in India in the first half of this calendar year.