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# Indian API Maker Hit with Warning Letter
- URL: https://www.fdaweb.com/indian-api-maker-hit-with-warning-letter/
- Published: 2025-05-13T12:00:00.000Z
- Updated: 2026-09-14T15:11:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159164

A 9/2024 inspection of Indian active pharmaceutical ingredient (API) manufacturer Mentha & Allied Products resulted in a just-posted [4/16 Warning Letter ](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mentha-allied-products-private-ltd-700242-04162025?ref=fdaweb.com)that cites the firm for significant GMP violations. The letter also takes issue with a 12/2024 response to the inspection’s Form FDA 483, saying that it is inadequate because the firm failed to provide supportive documentation support corrective actions taken to bring its operations into compliance. It recommends that firm retain a qualified consultant help it meet GMP requirements.

FDA investigators said the firm failed to properly maintain buildings and facilities used in its API manufacturing. For example, it “failed to maintain its drug manufacturing facility in a good state of repair,” the letter says. “The washroom used by operators was observed to be heavily soiled, and soap for handwashing was not available. In addition, the gowning room was observed to have dirty lockers, garments, and operator shoes.”

The letter also cites the firm’s quality unit for poor documentation practices and failing to implement adequate controls to ensure the integrity of data generated at its facility. “Our investigators observed unacceptable documentation practices, including, but not limited to, the following: torn batch records, a torn testing chromatogram found in the manufacturing area uncontrolled labeling and clearance forms in the packaging area, and a partially completed labeling and clearance form in an unlocked desk drawer,” the letter says.

Additionally, the letter also takes issue with the following:

- Failure to test the identity of each batch of incoming production material and to appropriately qualify suppliers to rely upon their certificate of analysis.
- Failure to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that its API conforms to established standards of quality.
- Failure to demonstrate that the manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.