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# 6 Observations on Piramal Pharma FDA-483
- URL: https://www.fdaweb.com/6-observations-on-piramal-pharma-fda-483/
- Published: 2025-02-26T12:00:00.000Z
- Updated: 2026-09-14T14:54:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158723

FDA has released the form FDA-483 issued following a 2/11-2/17 inspection at the Piramal Pharma Limited API (active pharmaceutical ingredient) manufacturing facility in Navi Mumbai, Maharashtra, India. The six inspection observations [were](https://www.fda.gov/media/185578/download?ref=fdaweb.com):

- failure to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
- failure of written records of investigation of an API to include follow-up;
- failure of written records of investigation of an API complaint to include adequate follow-up;
- cleaning of equipment is inadequate;
- failure of master production and control records to have complete manufacturing and control instructions, written specifications, and precautions to be followed; and
- failure to handle and store components, key starting materials, API containers, and closures at all times in a manner to prevent contamination and ensure satisfactory conformance to the identity and strength of each active ingredient.