# FDA 483 - Focus Scientific Services - December 16, 2022

Source: https://www.globalkeysolutions.net/records/483/focus-scientific-services/662b4e85-0771-4a2c-a8f4-2ca23183688d

> FDA 483 for Focus Scientific Services on December 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Focus Scientific Services
- Inspection Date: 2022-12-16
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Focus Scientific Services, a control testing laboratory in Palm Harbor, FL, received a Form 483 for failing to follow established test procedures and laboratory control mechanisms. The inspection revealed deficiencies including not confirming atypical microbiological growth, a technician not adhering to aseptic technique by failing to change gloves, and a lack of proper installation and operational qualification documentation for laboratory equipment like a laminar flow hood. These findings indicate significant non-compliance with internal protocols and quality control standards.

## Related Officers

- [Senior Manager, Executive Secretariat ](https://www.globalkeysolutions.net/people/jessica-m-simpson/94c06709-45cf-464f-92b4-ad3601ea20ab)
- [Shelby N. Turner](https://www.globalkeysolutions.net/people/shelby-n-turner/77268f33-ae48-4e30-abad-4d79c1077185)

Company: https://www.globalkeysolutions.net/companies/focus-scientific-services/5adc99b3-a178-4a62-82fc-f0d6987469b6

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