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# Cosco International CGMP Inspection Findings
- URL: https://www.fdaweb.com/cosco-international-cgmp-inspection-findings/
- Published: 2025-04-29T12:00:00.000Z
- Updated: 2026-09-14T15:10:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159080

A 10/15-10/25/2024 FDA inspection at the Cosco International drug manufacturing facility in Marietta, GA, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/14 Warning Letter says the specific violations were:

- failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products;
- failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failure of the firm’s quality control unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter says FDA has not received a company response to the inspection observations that were listed on a form FDA-483\. It also says the firm’s Carpe antiperspirant foot lotion and Carpe antiperspirant hand lotion are unapproved new drugs that can’t be legally marketed without agency approval and are misbranded.

FDA recommends that Cosco engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

Cosco was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.