# FDA 483 - CosMedical Technologies, LLC - March 22, 2019

Source: https://www.keypedia.com/records/483/cosmedical-technologies-llc/d0f41873-067b-4db8-8d86-f7b70b519818

> FDA 483 for CosMedical Technologies, LLC on March 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CosMedical Technologies, LLC
- Inspection Date: 2019-03-22
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Cosmedical Technologies, LLC, an OTC drug repacker and relabeler in Davie, FL, received a Form 483 with three observations. The firm failed to establish the reliability of supplier analyses for components and lacked strict control over drug product labeling operations. Additionally, employees were not provided with documented training in current good manufacturing practices for repacked and relabeled OTC drug products.

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## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.keypedia.com/companies/cosmedical-technologies-llc/d32097fc-6809-43ce-a4a8-a5e943f2d11e

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