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# Multiple Violations at Dr. Reddy’s Telangana Plant
- URL: https://www.fdaweb.com/multiple-violations-at-dr-reddys-telangana-plant/
- Published: 2019-02-19T12:00:00.000Z
- Updated: 2026-09-15T01:05:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143403

FDA has released the FDA-483 issued following a 1/30-2/8 inspection at Dr. Reddy’s Laboratories’ drug manufacturing facility in Telangana, India. The [form](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM631553.pdf?ref=fdaweb.com) contains 11 inspection observations, several of which are repeated from 2015 and/or 2017 inspections. The observations were: 

- procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed;
- the quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred;
- the quality control unit lacks the responsibility and authority to reject all drug products;
- appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
- responsibilities and procedures applicable to the quality control unit are not in writing and fully followed;
- master production and control records lack sampling and testing procedures;
- laboratory controls do not include a determination of conformance to written specifications for in-process materials;
- reserve drug product samples are not representative of each lot or batch of drug product;
- adequate lab facilities for testing and approval or rejection of in-process materials and drug products are not available to the quality control unit;
- the building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between drug products and to prevent contamination; and
- drains are not provided with an air break or other mechanical device to prevent back-siphonage where connected directly with a sewer.