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# CGMP Violations at Cosmax USA
- URL: https://www.fdaweb.com/cgmp-violations-at-cosmax-usa/
- Published: 2020-11-03T12:00:00.000Z
- Updated: 2026-09-14T16:35:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148004

A 2/24-3/17 FDA inspection at Cosmax USA, Ridgefield Park, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/15 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cosmax-usa-inc-606909-10152020?ref=fdaweb.com) says specific violations were: 

- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failing to establish time limits for the completion of each phase of production to assure the quality of the drug product; and
- failing to establish and follow adequate written procedures for cleaning and maintaining equipment.

The letter notes that the company manufactures multiple drugs that contain glycerin and refers the firm to a guidance on testing glycerin for diethylene glycol.

“Significant findings in this letter indicate that your quality unit is not able to fully exercise its authority and/or responsibilities,” FDA says. “Your firm must provide the quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality.”

The agency says it strongly recommends that Cosmax engage a qualified consultant to assist it in meeting CGMP requirements.

Cosmax was told to promptly correct the violations and to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the steps.