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# 8 Observations on Dr. Reddy’s FDA-483
- URL: https://www.fdaweb.com/8-observations-on-dr-reddys-fda-483/
- Published: 2019-08-29T12:00:00.000Z
- Updated: 2026-09-15T01:46:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144885

FDA has released the FDA-483 issued following an 8/12-8/20 inspection at the Dr. Reddy’s Laboratories drug manufacturing facility in Andhra, Pradesh, India. The inspection observations were: 

- the quality control unit lacks authority to fully investigate errors that have occurred;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process;
- deviations from written production and process control procedures are not justified;
- aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure;
- equipment for adequate control over air pressure, microorganisms, dust, humidity, and temperature is not provided when appropriate for the manufacture, processing, packing, or holding of a drug product;
- each lot of a component, drug product container, and closure that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use;
- control procedures are not established that validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product; and
- there is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.