> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Dr. Reddy’s Issued 10-item FDA-483
- URL: https://www.fdaweb.com/dr-reddys-issued-10-item-fda-483/
- Published: 2023-11-17T12:00:00.000Z
- Updated: 2026-09-14T14:16:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155815

FDA has issued Dr. Reddy’s Laboratories a [10-item Form FDA-483](http://www.fdaweb.com/download.php?file=Reddy%5FFDA-483-10-23.pdf) after concluding an inspection 10/27 at the firm’s Telangana, India manufacturing facility.

Agency investigators cited Dr. Reddy’s for not maintaining/cleaning equipment and utensils at appropriate intervals. They also took issue with the facility’s quality control unit for lacking adequate evaluations of equipment conditions.

The FDA-483 also documented deficient specification conformance determinations. For example, the agency said such determinations were deficient for the firm’s “total aerobic microbial count” and “total yeast and mold count” tests on purified water and its drug products.

Additionally, FDA said Dr. Reddy’s failed to thoroughly review any unexplained discrepancy and batch/component failures to meet specifications. For example, the 483 cited the quality control unit’s failure to conclude batch failure investigations, which resulted in the suspect products remaining in the U.S. market for months before eventually being recalled.