Dabur India Limited — FDA 483 Findings

Equipment surfaces that contact components and in-process materials ai·e reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the di11g product beyond the official or other established requirements.

The quality control unit lacks authority to review production records to assure that no e1Tors have occu1Ted and fully investigate e1Tors that have occmTed.

Procedures for the cleaning and maintenance of equipment ai·e deficient regai·ding the protection of clean equipment from contamination prior to use.

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

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.

Dmg product production and control records, are not reviewed and approved by the quality control unit to dete1mine compliance with all established, approved written procedures before a batch is released or distributed.

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