Infusion Systems of SW Florida Inc. dba Myerlee PharmacyAugust 11, 2022

FDA 483 - Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy - August 11, 2022

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Record Details

An FDA inspection of Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy in Fort Myers, FL, a producer of sterile and non-sterile products, revealed two significant observations. The firm failed to adequately evaluate products and take remedial action following microbial contamination in a cleanroom area. Additionally, the sterilization process for intrathecal products was found to be inadequate, specifically concerning sterility testing.

Company: Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy
Inspection Date: August 11, 2022
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
People: Steven A. Brettler (Consumer Safety Officer)
Jennifer Lalama

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ID · a2cf75e9-5de0-4f71-8e45-2985609af173