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# 8 Observations in Dr. Reddy’s FDA-483
- URL: https://www.fdaweb.com/8-observations-in-dr-reddys-fda-483-2/
- Published: 2018-11-14T12:00:00.000Z
- Updated: 2026-09-15T00:44:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142819

FDA has released the FDA-483 issued following a 10/22-10/30 inspection at Dr. Reddy’s Laboratories, Visakhapatnam, Andhra Pradesh, India. The inspection observations were: 

- failing to have written procedures for production and process controls to assure that drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product that may have been associated with the same failure or discrepancy;
- failing to establish or follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- failing to thoroughly review any unexplained discrepancy whether or not the batch has already been distributed;
- employees engaged in the manufacture and processing of drug product lack the training and experience to perform their assigned function;
- batch production and control records are deficient in that they do not include identification of persons performing each significant step in the operation; and
- a Field Alert Report was not submitted within three days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.