# FDA 483 - Darmerica, LLC - March 11, 2022

Source: https://www.globalkeysolutions.net/records/483/darmerica-llc/b8e293c0-3ea7-4303-8802-e0b9f47fbf02

> FDA 483 for Darmerica, LLC on March 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Darmerica, LLC
- Inspection Date: 2022-03-11
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Darmerica, LLC, a human and animal API repacker/relabeler in Casselberry, Florida, was cited for significant deficiencies across its quality system. Observations included inadequate supplier qualification and COA verification, improper storage of APIs, deficient controls for analytical equipment, failure to follow annual product review procedures, and inadequate cleaning procedures. These issues indicate a lack of robust quality control and adherence to established protocols.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.globalkeysolutions.net/companies/darmerica-llc/c7057426-4656-4edc-8759-9249315c155d

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