CosMedical Technologies, LLCMarch 22, 2019

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

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Record Details

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.

Company: CosMedical Technologies, LLC
Inspection Date: March 22, 2019
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
Person: Joanne E. King (Special Assistant)

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ID · d0f41873-067b-4db8-8d86-f7b70b519818