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# FDA Issues Form-483 to Alkem Labs in India
- URL: https://www.fdaweb.com/fda-issues-form-483-to-alkem-labs-in-india/
- Published: 2016-12-12T12:00:00.000Z
- Updated: 2026-09-14T21:53:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137542

FDA has issued Alkem Laboratories a three-item Form-483 after an inspection (12/5-9) recently concluded at the firm’s Ankleshwar, India active pharmaceutical ingredient manufacturing plant. The company said in a [financial release](http://corporates.bseindia.com/xml-data/corpfiling/AttachLive/F0DC32A3%5FB11C%5F44AC%5F8827%5FC64E218383B2%5F120105.pdf?ref=fdaweb.com) that it is preparing a detailed response with “adequate corrective and preventive measures” to address the agency’s observations. In September, Alkem’s Daman, India manufacturing plant received a 14-item Form-483 after an FDA inspection. The firm has 14 facilities in India and two in the U.S.