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# Dr. Reddy’s Form-483 Released
- URL: https://www.fdaweb.com/dr-reddys-form-483-released/
- Published: 2017-03-29T12:00:00.000Z
- Updated: 2026-09-14T22:14:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138323

A Dr. Reddy’s oncology drug formulation manufacturing facility at Duvvada, Visakhapatnam, India, that was one of the facilities named in a 2015 [Warning Letter](http://fdaweb.com/fdaweb.com/login.php?sa=v&aid=D5133888&searchWords=dr.%20reddy&cate=S&stid=%241%244S0.5V3.%24ut2zt57QqJUbHf2622ksy1&ref=fdaweb.com), has been issued a 13-item [Form-483](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM547646.pdf?ref=fdaweb.com). The February inspection cited the firm for failing to thoroughly review any unexplained discrepancy whether or not the batch has already been distributed. It also found that a review of trending data on documentation errors found no critical evaluation of the data based on 314 errors in 22 batch manufacturing records.

  
Last month, FDA [issued](https://www.fdaweb.com/agency-cites-dr-reddys-again-after-inspection/) a three-observation FDA-483 for Dr. Reddy’s Miryalaguda active pharmaceutical ingredients plant in Telangana, India. That facility was also included in the 2015 Warning Letter.