Ms. Susana Elizabeth Garcia Ballesteros
Director
Notarika, S.A. de C.V.
Eléctrica de México No. 41 Vista Hermosa
54080 Tlalnepantla de Baz , Méx.
MexicoFEI 3017177797Issued Oct 7, 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 3017177797.
Violations5
Issue DateOct 7, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Notarika, S.A. de C.V.
Location
Ms. Susana Elizabeth Garcia Ballesteros
Director
Notarika, S.A. de C.V.
Eléctrica de México No. 41 Vista Hermosa
54080 Tlalnepantla de Baz , Méx.
Mexico
FEI Number
3017177797
Country
Mexico
Issue Date
October 07, 2021
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Notarika, S.A. de C.V. was warned for manufacturing Greenfrog Hand Sanitizer, an unapproved new drug that violated multiple provisions of the Federal Food, Drug, and Cosmetic Act, including being adulterated due to ingredient substitution and failing to meet Current Good Manufacturing Practice (CGMP) quality assurance requirements. FDA laboratory testing of batches detained at the U.S. border confirmed that the product contained substituted substances, demonstrating inadequate quality control at the facility. The product was also found to be misbranded under multiple FD&C Act sections related to labeling and drug approval status.
Notarika, S.A. de C.V. FDA Warning Letter, October 7, 2021
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