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# 31 Apotex ANDAs Withdrawn Over Inspection Concerns
- URL: https://www.fdaweb.com/31-apotex-andas-withdrawn-over-inspection-concerns/
- Published: 2019-07-09T12:00:00.000Z
- Updated: 2026-09-15T01:36:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144482

*Federal Register* notice: FDA is withdrawing approval of 31 Apotex ANDAs after the company requested that they be withdrawn due to FDA inspection concerns. After the drugs were approved, FDA says it became aware of concerns involving material manufactured at two Apotex facilities, at least one of which was named in each of the applications. The facilities involved were Apotex Private Research Ltd. and Apotex Pharmachem India Private Ltd. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-14660.pdf?ref=fdaweb.com).