6 Observations on Piramal Pharma FDA-483
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:
- 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.