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# 3 Observations on Reliance Life Sciences FDA-483
- URL: https://www.fdaweb.com/3-observations-on-reliance-life-sciences-fda-483/
- Published: 2026-08-13T12:00:00.000Z
- Updated: 2026-09-14T13:45:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161621

FDA has released the Form FDA-483 with three observations from a 2/19-2/27 inspection at the Reliance Life Sciences Private Limited drug manufacturing facility in Navi Mumbai, Maharashtra, India. The observations were:

- failure of laboratory records to include complete data derived from all tests, examinations, and assay necessary to assure compliance with established specifications and standards;
- failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the sterilization process; and
- failure of written records of investigations into unexplained discrepancies to always include the conclusions and follow-up.