Mr. Sanjoy Banerjee
Executive Chairman and CEO
Urban Electric Power
401 N Middletown Road, B155
Pearl River , NY 10965
United StatesFEI 3016759092Issued Dec 27, 2022Division of Pharmaceutical Quality Operations I
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 3016759092.
Violations3
Issue DateDec 27, 2022
Product TypeDrugs
StatusOpen
Letter Details
Firm
Urban Electric Power
Location
Mr. Sanjoy Banerjee
Executive Chairman and CEO
Urban Electric Power
401 N Middletown Road, B155
Pearl River , NY 10965
United States
FEI Number
3016759092
Country
United States
Issue Date
December 27, 2022
Issuing Office
Division of Pharmaceutical Quality Operations I
Product Type
Drugs
Status
Open
Summary
Urban Electric Power, an OTC drug manufacturer, was cited for producing hand sanitizer products contaminated with unacceptable levels of acetaldehyde and acetal impurities, rendering them adulterated. FDA testing of four batches revealed these contaminants across all samples, indicating that the company's quality assurance and manufacturing controls failed to meet Current Good Manufacturing Practice (CGMP) requirements. The company's response to FDA's July 2022 information request demonstrated that their manufacturing methods, facilities, and controls continued to fall short of CGMP standards. The firm had distributed hand sanitizer products as recently as August 31, 2022, and was deregistered as a drug manufacturer on October 24, 2022.
Urban Electric Power FDA Warning Letter, December 27, 2022