# FDA 483 - CosMedical Technologies, LLC - July 07, 2025

Source: https://www.globalkeysolutions.net/records/483/cosmedical-technologies-llc/ae30c274-e467-4e04-a5f0-5c6f0e14e781

> FDA 483 for CosMedical Technologies, LLC on July 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CosMedical Technologies, LLC
- Inspection Date: 2025-07-07
- Product Type: drugs
- Office Name: Florida District Office
- Summary: An FDA inspection of CosMedical Technologies, LLC, an OTC drug repacker and labeler in Davie, FL, revealed significant deficiencies in its quality control systems. The firm failed to perform essential finished product testing, manage customer complaints effectively, and adequately oversee contract manufacturers. Multiple procedural failures were noted, including a lack of batch record review, microbiological testing, annual product reviews, cGMP training, and proper label storage, alongside the absence of a stability testing program and incoming packaging material inspection.

## Related Documents

- [483 - 2019-03-22](https://www.globalkeysolutions.net/records/483/cosmedical-technologies-llc/d0f41873-067b-4db8-8d86-f7b70b519818)

## Related Officers

- [Director of Compliance Branch](https://www.globalkeysolutions.net/people/ronda-r-lloyd-jones/1446ba41-f1f2-4d40-8902-021b2bef3a53)
- [Mickell Smith](https://www.globalkeysolutions.net/people/mickell-smith/ef92e41a-a16b-488a-a217-b10b54bb4f73)
- [Michael Z. Weigman](https://www.globalkeysolutions.net/people/michael-z-weigman/fcf79bb1-87cc-476c-a1af-758ef0126ee9)

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

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9