# FDA 483 - Pharmetric Laboratory LLC - November 06, 2023

Source: https://www.globalkeysolutions.net/records/483/pharmetric-laboratory-llc/b84d19b3-7912-42fe-9a32-be7df778d584

> FDA 483 for Pharmetric Laboratory LLC on November 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmetric Laboratory LLC
- Inspection Date: 2023-11-06
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Pharmetric Laboratory LLC, a contract testing laboratory in St Petersburg, FL, revealed significant deficiencies within its Quality Control unit. The unit failed to identify issues including incomplete non-conformance logs, untimely investigations, inadequate separation of quarantined materials, and an analyst's non-compliance with documentation procedures for endotoxin analysis. These findings indicate a lack of adherence to established quality control responsibilities and procedures.

## Related Officers

- [Pharmaceutical Investigator](https://www.globalkeysolutions.net/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)

Company: https://www.globalkeysolutions.net/companies/pharmetric-laboratory-llc/f348ac42-73e4-4618-b9de-c809eaa48d97

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