FDA 483 - Emcure Pharmaceuticals Limited - February 25, 2025

Emcure Pharmaceuticals Limited, located in Pune, Maharashtra, India, underwent an FDA inspection from February 19 to February 25, 2025. The inspection revealed significant compliance issues primarily related to equipment cleaning and maintenance, as well as deficiencies in training documentation. Key observations included the failure to establish and follow adequate written procedures for cleaning and maintaining equipment, which could lead to contamination. Specific issues were noted with cleaning validation for vessels and tanks, improper use of non-cleanable materials, and lack of objective cleaning criteria. Additionally, there were maintenance issues such as physical deterioration of equipment that were not addressed in preventive maintenance protocols.

The inspection also highlighted deficiencies in the documentation and verification of training records. The current system does not require individual trainees to verify their completion of group training, and records are entered by trainers without individual authentication. This lack of documentation raises concerns about whether personnel have received and understood necessary training.

These observations were reported under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, which mandates that firms ensure their products are not prepared, packed, or held under insanitary conditions. Emcure Pharmaceuticals is required to conduct internal audits to identify and rectify these violations to comply with FDA regulations. The company is advised to submit corrective actions to the FDA for review.