Dabur India Limited — FDA 483 Findings

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

Equipment surfaces that contact components and in-process materials are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.

Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use.

Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.

Written procedures are not established and followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.

Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds insects, and other vermin.