Ms. Sofia Corona Gonzalez
Laboratory and Production Manager
Grupo Yacana Mexico, S.A.S. de C.V.
Av. Alfonso Reyes No. 714
Country la Silla Sector 4
67173 Guadalupe , N.L.
MexicoFEI 3015123543Issued Jan 26, 2021Center 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 3015123543.
Violations3
Issue DateJan 26, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Grupo Yacana Mexico, S.A.S. de C.V.
Location
Ms. Sofia Corona Gonzalez
Laboratory and Production Manager
Grupo Yacana Mexico, S.A.S. de C.V.
Av. Alfonso Reyes No. 714
Country la Silla Sector 4
67173 Guadalupe , N.L.
Mexico
FEI Number
3015123543
Country
Mexico
Issue Date
January 26, 2021
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Grupo Yacana Mexico was cited for manufacturing unapproved and misbranded antiseptic hand rub products labeled as containing 70% alcohol that were detained at the U.S. border. FDA laboratory testing found the products were adulterated due to substitution of active ingredients (section 501(d)(2) of the FD&C Act) and in one batch, substandard strength, purity, or quality (section 501(c)). The company had recently registered as a human drug manufacturer but failed to ensure its hand sanitizer products met required specifications and were properly approved for U.S. distribution.
Grupo Yacana Mexico, S.A.S. de C.V. FDA Warning Letter, January 26, 2021
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