Custom Research Labs Inc.

Warning LetterOpen

Mr. Steven Kim Chief Executive Officer Custom Research Labs Inc. 432 W. Alondra Blvd. Gardena , CA 90248-2425 United States steve@customresearchlabs.comFEI 3008268262Issued Jul 8, 2022Division of Pharmaceutical Quality Operations IV

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Violations12

Issue DateJul 8, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Custom Research Labs Inc.
Location: Mr. Steven Kim Chief Executive Officer Custom Research Labs Inc. 432 W. Alondra Blvd. Gardena , CA 90248-2425 United States steve@customresearchlabs.com
FEI Number: 3008268262
Country: United States
Issue Date: July 08, 2022
Issuing Office: Division of Pharmaceutical Quality Operations IV
Product Type: Drugs
Status: Open

Summary

Custom Research Labs Inc. manufactured adulterated drug products, including hand sanitizers, that failed to comply with current good manufacturing practice (CGMP) regulations. FDA inspectors found that the company did not adequately test incoming components such as active pharmaceutical ingredients (camphor and menthol) and deionized water for identity, purity, strength, and quality, nor did it validate or establish the reliability of supplier test analyses at appropriate intervals, as required by 21 CFR 211.84(d). The hand sanitizer products were also marketed as unapproved new drugs and misbranded in violation of the Federal Food, Drug, and Cosmetic Act. The inspection occurred June 1-4, 2021, at the company's Gardena, California facility.

Custom Research Labs Inc. FDA Warning Letter, July 8, 2022