Mr. David M. Rose
CEO and Co-Owner
Atlanta Supersource, Inc.
3655 Kennesaw 75 Parkway NW, Suite 100
Kennesaw , GA 30144-6502
United StatesFEI 3016837288Issued Jan 8, 2025Center 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 3016837288.
Violations6
Issue DateJan 8, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Atlanta Supersource, Inc.
Location
Mr. David M. Rose
CEO and Co-Owner
Atlanta Supersource, Inc.
3655 Kennesaw 75 Parkway NW, Suite 100
Kennesaw , GA 30144-6502
United States
FEI Number
3016837288
Country
United States
Issue Date
January 08, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Atlanta Supersource, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations at its drug manufacturing facility in Kennesaw, Georgia, involving the production of INSTANT HAND SANITIZER Rinse-Free Gel and Rinse-Free Foam products. The FDA found that the company failed to properly clean, maintain, sanitize, and sterilize manufacturing equipment and utensils at appropriate intervals, resulting in adulterated drug products that were also misbranded. The company's response to the initial FDA 483 inspection findings was deemed inadequate, lacking sufficient detail and evidence of corrective actions needed to achieve CGMP compliance.
Atlanta Supersource, Inc. FDA Warning Letter, January 8, 2025