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# Quality CDMO Marketing Unapproved Drugs: FDA
- URL: https://www.fdaweb.com/quality-cdmo-marketing-unapproved-drugs-fda/
- Published: 2024-09-17T12:00:00.000Z
- Updated: 2026-09-14T14:41:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157788

A 6/12-6/16/2023 FDA inspection at the Quality CDMO drug manufacturing facility in Fort Worth, TX, found the company produces drug products that are legally considered to be unapproved new drugs. A 9/11 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/quality-cdmo-inc-665961-09112024?ref=fdaweb.com) reviews claims made for five drug products that are not generally recognized as safe and effective for their uses and therefore are considered to be unapproved new drugs.

The firm was told to take prompt action to address the violations and to respond with a list of specific steps it has taken to bring the company into compliance with the law by correcting the violations and preventing their recurrence, with a schedule for completing the corrections.