Acella Pharmaceuticals, LLCJanuary 7, 2020

FDA 483 - Acella Pharmaceuticals, LLC - January 07, 2020

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Record Details

Acella Pharmaceutical Service, LLC in Alpharetta, GA, was cited for significant deficiencies in its quality control unit and complaint handling procedures. The firm failed to adequately investigate product complaints, verify product quality data, and properly assess and report serious adverse events related to its NP Thyroid medication. Additionally, the firm did not consistently reply to complainants, even when requested.

Company: Acella Pharmaceuticals, LLC
Inspection Date: January 7, 2020
Product Type: Drugs
Office: Atlanta District Office
People: Veronica Fuentes (Pharmaceutical Specialist/ Investigator )
Gideon N. Esuzor (Investigator)

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ID · 6188daa7-af89-4c87-b4d2-e63014b71d59