> ## 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 Deviations at Centaur Pharmaceuticals
- URL: https://www.fdaweb.com/cgmp-deviations-at-centaur-pharmaceuticals/
- Published: 2023-07-18T12:00:00.000Z
- Updated: 2026-09-14T18:44:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154893

An 11/14-11/21/22 FDA inspection at Centaur Pharmaceuticals Private Ltd. in Mumbai, India, identified significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A just-released 6/5 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centaur-pharmaceuticals-private-ltd-651080-06052023?ref=fdaweb.com) says the specific deviations were:

- failure of the quality unit to exercise its responsibility to ensure the API manufactured at the facility comply with CGMP; and
- failing to clear equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications.

Centaur was told to correct any deviations promptly and to respond with a list of specific steps it has taken to address the deviations and prevent their recurrence, with a schedule for completing the corrections.