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# Alkem Inspection Has 4 Observations
- URL: https://www.fdaweb.com/alkem-inspection-has-4-observations/
- Published: 2019-08-23T12:00:00.000Z
- Updated: 2026-09-15T01:45:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144849

An 8/16-8/22 FDA inspection at the Alkem Laboratories drug manufacturing facility at Fenton, MO, resulted in issuance of an FDA-483 with four inspection observations, according to an online *Equity Bulls* [post](ttps://www.equitybulls.com/admin/news2006/news%5Fdet.asp?id=255818). The agency also inspected the company’s Baddi, India, manufacturing facility from 8/19 to 8/23, and did not issue an FDA-483\. The company said it will put together a detailed response with adequate corrective and preventive measures to address deficiencies at the Fenton facility, the post says.