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# CGMP Violations at Fareva Morton Grove
- URL: https://www.fdaweb.com/cgmp-violations-at-fareva-morton-grove/
- Published: 2026-03-10T12:00:00.000Z
- Updated: 2026-09-14T13:35:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160791

An 8/4-8/12/2025 FDA inspection at the Fareva drug manufacturing facility in Morton Grove, IL, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/3 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fareva-morton-grove-719408-03032026https:/www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fareva-morton-grove-719408-03032026https:/www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fareva-morton-grove-719408-03032026https:/www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fareva-morton-grove-719408-03032026?ref=fdaweb.com) says the three specific violations were:

- failure to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance;
- failure to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms; and
- failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards.

FDA says some of the products that Fareva manufactures may be regulated as cosmetics. It says the firm’s responses to the inspection observations were not adequate. The company was told to promptly correct the violations and to provide a list of specific actions taken to address them and prevent their recurrence, along with a schedule for completing the corrections.