Ms. Kelly Ann Lewis-Bortman
Manager/Co-Owner
Global Sanitizers LLC
175 E. Warm Springs Road
Las Vegas , NV 89119
United States
kelly@globalsanitizers.comFEI 3016413581Issued Nov 8, 2021Division of Pharmaceutical Quality Operations IV
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 3016413581.
Violations8
Issue DateNov 8, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Global Sanitizers LLC
Location
Ms. Kelly Ann Lewis-Bortman
Manager/Co-Owner
Global Sanitizers LLC
175 E. Warm Springs Road
Las Vegas , NV 89119
United States
kelly@globalsanitizers.com
FEI Number
3016413581
Country
United States
Issue Date
November 08, 2021
Issuing Office
Division of Pharmaceutical Quality Operations IV
Product Type
Drugs
Status
Open
Summary
Global Sanitizers LLC received a warning for manufacturing and distributing adulterated hand sanitizer products under the business name "SBL Brands LLC" that failed to meet current good manufacturing practice (CGMP) standards for finished pharmaceuticals. FDA testing confirmed the products contained substituted substances, violating section 501(d)(2) of the Federal Food, Drug and Cosmetic Act. The company had also failed to respond to two FDA requests for records and information sent in December 2020, constituting a refusal to permit access as required by law. The violations encompassed deficiencies in the company's methods, facilities, and controls for manufacturing, processing, packing, and holding of drug products.
Global Sanitizers LLC FDA Warning Letter, November 8, 2021