# FDA 483 - Florida Cirtech Inc - June 08, 2021

Source: https://www.globalkeysolutions.net/records/483/florida-cirtech-inc/9b745975-807a-42d0-abef-b45ebf13ee24

> FDA 483 for Florida Cirtech Inc on June 08, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Florida Cirtech Inc
- Inspection Date: 2021-06-08
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Florida Cirtech Inc, a drug product manufacturer in Greeley, CO, revealed significant deficiencies in its quality control systems. The firm failed to establish appropriate specifications for hand sanitizer, did not adequately qualify raw material suppliers, and lacked proper procedures for handling and investigating product complaints and adverse events. These issues indicate a serious lack of control over product quality and safety.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/dustin-m-james/bf423ddc-721b-4049-9eb1-3bc0fdb44441)
- [Senior Lead Reviewer and Intercenter Consult Team Leader](https://www.globalkeysolutions.net/people/nayan-j-patel/0436f014-4b1b-4e54-8df0-576d51a354b2)

Company: https://www.globalkeysolutions.net/companies/florida-cirtech-inc/98533d14-db4a-40a8-8008-b1ca42dedf72

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face