Cosco International, Inc.

Warning LetterOpen

Mr. Peter M. Hoffman Chief Operating Officer Cosco International, Inc. 1633 Sands Pl SE Marietta , GA 30067-8785 United StatesFEI 3000220439Issued Apr 14, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3000220439.

Violations4

Issue DateApr 14, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Cosco International, Inc.
Location: Mr. Peter M. Hoffman Chief Operating Officer Cosco International, Inc. 1633 Sands Pl SE Marietta , GA 30067-8785 United States
FEI Number: 3000220439
Country: United States
Issue Date: April 14, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Cosco International, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of finished pharmaceutical drugs, including unapproved new drugs and misbranded products such as "Carpe ANTIPERSPIRANT FOOT LOTION" and "Carpe ANTIPERSPIRANT HAND LOTION." The company failed to establish adequate written procedures for production and process control to ensure drug products had the identity, strength, quality, and purity they claimed to possess, and did not implement proper process validation for its over-the-counter drug manufacturing. The FDA had not received a response from the company addressing deficiencies identified during the October 2024 inspection before issuing this warning letter in April 2025.

Cosco International, Inc. FDA Warning Letter, April 14, 2025