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483
•US Infusion, Inc.•March 6, 2023

US Infusion, Inc. – FDA 483, Mar 6, 2023

Record Details

US Infusion, Inc. in South Miami, FL, a specification developer, was inspected by the FDA and received two observations. The inspection revealed deficiencies in establishing adequate quality agreements with contract manufacturers and in documenting corrective and preventive actions for product complaints, specifically regarding leaking IV administration sets.

Company
US Infusion, Inc.
Inspection date
March 6, 2023
Product type
other
Office
Office of Medical Device and Radiological Health Division II
Person
  • Ronald Ifraimov (investigator)
View Company Profile

ID · b165e212-36fb-4fe7-89a1-ee77a35897df

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