Petnet Solutions IncJanuary 20, 2023

FDA 483 - Petnet Solutions Inc - January 20, 2023

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Record Details

An FDA inspection of Petnet Solutions Inc in Fort Lauderdale, FL, revealed significant deficiencies in quality control and facility contamination prevention. The firm failed to take appropriate corrective actions for out-of-specification endotoxin results and conducted retesting without proper invalidation. Additionally, the facility's environmental monitoring program was found inadequate, posing a risk of product contamination.

Company: Petnet Solutions Inc
Inspection Date: January 20, 2023
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
Person: Saundrea A. Munroe (Drug Specialist / Drug Investigator)

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ID · 1acb274c-7dde-47e3-87dd-c97092c76271