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# Five Observations at Dr. Reddy Telengana Plant
- URL: https://www.fdaweb.com/five-observations-at-dr-reddy-telengana-plant/
- Published: 2018-03-22T12:00:00.000Z
- Updated: 2026-09-14T23:54:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141045

FDA has released the [FDA-483](https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm602253.htm?ref=fdaweb.com) with five observations from a 3/5-3/9 inspection at the Dr. Reddy’s Laboratories active pharmaceutical ingredient (API) manufacturing facility in Medak, Telengana, India. The observations were: 

- failing to fully follow responsibilities and procedures applicable to the quality control unit;
- failing to follow procedures describing the handling of written and oral complaints related to API materials;
- failing to maintain buildings used in the manufacturing, processing, and packing of API finished materials in a good state of repair;
- separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of API finished materials prior to release; and
- failing to assure that equipment used in the production of specified APIs are always maintained and/or kept in/under proper conditions for manufacturing operations and to prevent the contamination of the products handled and/or processed in the equipment.

Earlier this year the agency released an [FDA-483](https://www.fdaweb.com/fda-releases-dr-reddys-establishment-report/) with 13 observations following an inspection at another Dr. Reddy’s facility in India. And it expressed concerns about Dr. Reddy’s facilities in the UK and India on at least eight occasions in 2017.