Elmar Giovanni Cardona Quintana
President
Genesis Partnership Company SA
Km 19.5 Carrtera Al Pacifico, Bodega 28
01064 - Villa Nueva
GuatemalaFEI 3016785739Issued Dec 29, 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 3016785739.
Violations1
Issue DateDec 29, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Genesis Partnership Company SA
Location
Elmar Giovanni Cardona Quintana
President
Genesis Partnership Company SA
Km 19.5 Carrtera Al Pacifico, Bodega 28
01064 - Villa Nueva
Guatemala
FEI Number
3016785739
Country
Guatemala
Issue Date
December 29, 2021
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Genesis Partnership Company SA was cited for marketing Bathletix Hand Sanitizer, an alcohol-based over-the-counter hand sanitizer bearing Major League Baseball and NBA team logos, as a misbranded drug under section 502(i) of the Federal Food, Drug, and Cosmetic Act. The product violated FDA regulations because it made disease-prevention claims ("help reduce bacteria that potentially can cause disease") and included drug-specific labeling elements such as "Drug Facts" and usage directions that established its intended use as a topical antiseptic, yet failed to comply with the applicable regulatory requirements for such drugs. The product had been in interstate commerce since June 2020 in 8-ounce bottles distributed throughout the United States.
Genesis Partnership Company SA FDA Warning Letter, December 29, 2021