Sanit Technologies, LLC dba DurisanMarch 5, 2021

FDA 483 - Sanit Technologies, LLC dba Durisan - March 05, 2021

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Record Details

Sanit Technologies, LLC dba Durisan, an OTC drug manufacturer in Sarasota, FL, was cited for significant deficiencies in its quality control unit, manufacturing processes, and laboratory controls. The inspection revealed failures to investigate out-of-specification results, including microbial contamination in water and finished products, and a lack of proper validation for equipment and processes. Repeat observations from a previous inspection indicate persistent issues with CGMP compliance.

Company: Sanit Technologies, LLC dba Durisan
Inspection Date: March 5, 2021
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
People: Kayla V. Sprague (Pharmaceutical Investigator)
Saundrea A. Munroe (Drug Specialist / Drug Investigator)

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ID · 72616c46-474b-4007-a016-89cd878fd2d5