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FDA Warning Letter Explorer
FDA warning letter · Drugs

Centaur Pharmaceuticals Private Ltd.

Issued · Posted by FDA

FDA published a close-out letter on Jul 21, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.

Passage 2

Failure to clean 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.

Passage 3

You failed to have adequate procedures for cleaning and maintenance of manufacturing equipment. Our investigators observed manufacturing equipment labeled “Cleaned” and found the following deficiencies. For example: