Mr. Joel Gutiérrez Antonio
Director General/CEO
Nanomateriales Químicos Avanzados, S.A. de C.V.
Av Milimex 215
Col. Parque Industrial Milimex
66637 Apodaca , N.L.
MexicoFEI 3010525809Issued Sep 15, 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 3010525809.
Violations7
Issue DateSep 15, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Nanomateriales Químicos Avanzados, S.A. de C.V.
Location
Mr. Joel Gutiérrez Antonio
Director General/CEO
Nanomateriales Químicos Avanzados, S.A. de C.V.
Av Milimex 215
Col. Parque Industrial Milimex
66637 Apodaca , N.L.
Mexico
FEI Number
3010525809
Country
Mexico
Issue Date
September 15, 2021
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Nanomateriales Químicos Avanzados, S.A. de C.V., a Mexican manufacturer of over-the-counter hand sanitizer products, was cited for manufacturing adulterated drugs in which substances were wholly or partially substituted, as demonstrated by FDA laboratory testing of a ZANILAST + Gel batch detained at the U.S. border. The company failed to maintain current good manufacturing practice (CGMP) standards for finished pharmaceuticals, with deficiencies identified in manufacturing methods, facility controls, and quality assurance processes that did not conform to 21 CFR parts 210 and 211.
Nanomateriales Químicos Avanzados, S.A. de C.V. FDA Warning Letter, September 15, 2021
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