# FDA 483 - Darmerica, LLC - March 18, 2025

Source: https://www.keypedia.com/records/483/darmerica-llc/29f0be5e-38fa-454e-a6da-5bf75837a7a8

> FDA 483 for Darmerica, LLC on March 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Darmerica, LLC
- Inspection Date: 2025-03-18
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Darmerica, LLC, an active pharmaceutical importer, repacker, and relabeler in Davie, FL, received a Form 483 with six observations. The inspection revealed significant deficiencies in quality control, including releasing products without complete testing, failing to verify drug identity, inadequate complaint investigations, and poor supplier qualification. These issues indicate a systemic breakdown in ensuring product quality and regulatory compliance.

## Related Documents

- [483 - 2019-07-18](https://www.keypedia.com/records/483/darmerica-llc/bcdfeacd-3b2c-4109-b8f7-15aea715f1b0)
- [483 - 2025-03-19](https://www.keypedia.com/records/483/darmerica-llc/a0879f6b-8de0-4ddf-8d65-322b0b492916)
- [WARNING_LETTER - 2025-03-19](https://www.keypedia.com/records/warning_letter/darmerica-llc/13cb7bd4-5c85-4bc4-9ad4-cde3a0ad30bb)

## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)
- [Mawany E. Kamwy](https://www.keypedia.com/people/mawany-e-kamwy/72b047b6-7f29-44c3-a8dd-9679b1a28f96)

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

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