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

Source: https://www.globalkeysolutions.net/records/483/sanit-technologies-llc-dba-durisan/72616c46-474b-4007-a016-89cd878fd2d5

> FDA 483 for Sanit Technologies, LLC dba Durisan on March 05, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanit Technologies, LLC dba Durisan
- Inspection Date: 2021-03-05
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Documents

- [483 - 2019-05-17](https://www.globalkeysolutions.net/records/483/sanit-technologies-llc-dba-durisan/b83eab5c-a210-468d-a731-65001332edd2)
- [WARNING_LETTER - 2020-04-15](https://www.globalkeysolutions.net/records/warning_letter/sanit-technologies-llc-dba-durisan/d774448b-fcea-43b1-9d6a-ea207b798014)
- [WARNING_LETTER - 2021-03-05](https://www.globalkeysolutions.net/records/warning_letter/sanit-technologies-llc-dba-durisan/99db819a-4031-4e71-8561-ef607a06e726)

## Related Officers

- [Pharmaceutical Investigator](https://www.globalkeysolutions.net/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)
- [Drug Specialist  / Drug Investigator](https://www.globalkeysolutions.net/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.globalkeysolutions.net/companies/sanit-technologies-llc-dba-durisan/789827e7-91bb-43fc-9bf0-f17a5bd59309

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6