Mr. Michael Wetzer/Dr. Joseph Antoun
Chief Executive Officer/Chief Scientific Officer
Sanit Technologies, LLC dba Durisan
7810 25th Court East Unit 106
Sarasota , FL 34243-2841
United StatesFEI 3014538924Issued Jul 27, 2021Office of Pharmaceutical Quality Operations, Division II
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 3014538924.
Violations1
Issue DateJul 27, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Sanit Technologies, LLC dba Durisan
Location
Mr. Michael Wetzer/Dr. Joseph Antoun
Chief Executive Officer/Chief Scientific Officer
Sanit Technologies, LLC dba Durisan
7810 25th Court East Unit 106
Sarasota , FL 34243-2841
United States
FEI Number
3014538924
Country
United States
Issue Date
July 27, 2021
Issuing Office
Office of Pharmaceutical Quality Operations, Division II
Product Type
Drugs
Status
Open
Summary
Sanit Technologies, LLC dba Durisan, a drug manufacturer, violated current good manufacturing practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection in March 2021. The company's quality control unit failed to properly oversee batch release and distributed Durisan Hand Sanitizer, Alcohol-Free products that did not meet specifications for microbial contamination, including identification of Burkholderia cepacia (an opportunistic pathogen) in multiple lots released between April and December 2020. These manufacturing and quality control failures rendered the drug products adulterated and unfit for distribution to consumers.
Sanit Technologies, LLC dba Durisan FDA Warning Letter, July 27, 2021
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