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# FDA Hits Dr. Reddy’s Plant with 7-Item 483
- URL: https://www.fdaweb.com/fda-hits-dr-reddys-plant-with-7-item-483/
- Published: 2025-08-11T12:00:00.000Z
- Updated: 2026-09-14T15:18:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159659

FDA has issued Dr. Reddy's Laboratories a seven-item Form FDA-483 after inspecting the firm’s sterile drug manufacturing facility in Andhra Pradesh, India. According to the FDA-483, the agency cited the following:

- Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.
- Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
- Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
- Equipment used in the manufacture, processing, packing or holding of drug products is not of adequate size to facilitate operations for its intended use.
- Examination and testing of samples is not done to assure that in-process materials conform to specifications.
- Drug product production and control records are not reviewed and approved by the quality control unit to determine compliance with all established and approved written procedures before a batch is released or distributed.
- There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has already been distributed.

To view the inspection report, click [here](http://file///C:/Users/dave/Downloads/dr.%5Freddys%5Flaboratories%5Fandhra%5Fpradesh%5Findia%5F7.10-7.18.25%5F483%5Fredacted%5F0.pdf?ref=fdaweb.com).