# FDA 483 - Darmerica, LLC - July 18, 2019

Source: https://www.globalkeysolutions.net/records/483/darmerica-llc/bcdfeacd-3b2c-4109-b8f7-15aea715f1b0

> FDA 483 for Darmerica, LLC on July 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Darmerica, LLC
- Inspection Date: 2019-07-18
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Darmerica, LLC, an API repacker/relabeler in Casselberry, FL, was inspected by the FDA. The inspection revealed significant deficiencies in quality control, including a lack of OOS investigations for temperature excursions, inadequate supplier qualification and material release procedures, and unqualified/unvalidated equipment for API storage and transport. These issues indicate a severe lack of control over the quality and integrity of active pharmaceutical ingredients.

## Related Documents

- [483 - 2025-03-18](https://www.globalkeysolutions.net/records/483/darmerica-llc/29f0be5e-38fa-454e-a6da-5bf75837a7a8)
- [WARNING_LETTER - 2025-03-19](https://www.globalkeysolutions.net/records/warning_letter/darmerica-llc/13cb7bd4-5c85-4bc4-9ad4-cde3a0ad30bb)

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.globalkeysolutions.net/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.globalkeysolutions.net/companies/darmerica-llc/ff6fa87e-2dbc-4215-a76f-630e5e1c9030

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