# FDA 483 - Sanit Technologies, LLC dba Durisan - May 17, 2019

Source: https://www.globalkeysolutions.net/records/483/sanit-technologies-llc-dba-durisan/b83eab5c-a210-468d-a731-65001332edd2

> FDA 483 for Sanit Technologies, LLC dba Durisan on May 17, 2019. 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: 2019-05-17
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Durisan, an OTC drug product manufacturer in Sarasota, FL, was cited for numerous significant deficiencies during an FDA inspection. The firm lacked a functional quality control unit, proper batch records, adequate laboratory controls with established specifications, and essential procedures for water system sampling, equipment cleaning, and employee training. These issues indicate a severe lack of control over manufacturing processes and product quality.

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## Related Officers

- [Libia Lugo](https://www.globalkeysolutions.net/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)

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

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9