Mr. Alexis Bellon
Director General
Industrias Cklass S. de R.L. de C.V.
Avenida Ignacio L. Vallarta No. 4030 San Jorge
44090 Guadalajara , Jal.
Mexico
info@cklass.com.mxFEI 3016734550Issued Jun 22, 2022Center for Drug Evaluation and Research | CDER
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 3016734550.
Violations3
Issue DateJun 22, 2022
Product TypeDrugs
StatusOpen
Letter Details
Firm
Industrias Cklass S. de R.L. de C.V.
Location
Mr. Alexis Bellon
Director General
Industrias Cklass S. de R.L. de C.V.
Avenida Ignacio L. Vallarta No. 4030 San Jorge
44090 Guadalajara , Jal.
Mexico
info@cklass.com.mx
FEI Number
3016734550
Country
Mexico
Issue Date
June 22, 2022
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Industrias Cklass S. de R.L. de C.V. manufactured an unapproved hand sanitizer product labeled "cklass Hand Sanitizer WITH ALOE ENRICHED WITH MOISTURIZING AND EMOLLIENT AGENTS" that was detained at the U.S. border and found to be adulterated due to substance substitution, indicating a failure in quality assurance and Current Good Manufacturing Practice (CGMP) compliance. The product violated multiple FD&C Act provisions by being introduced into interstate commerce as an unapproved new drug and misbranded under sections 502(j), (a), (e), and (ee). FDA laboratory testing demonstrated that the company's quality assurance systems were not functioning in accordance with CGMP requirements.
Industrias Cklass S. de R.L. de C.V. FDA Warning Letter, June 22, 2022
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