Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy – FDA 483, Aug 11, 2022
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.
- Inspection date
- August 11, 2022
- Product type
- drugs
ID · a2cf75e9-5de0-4f71-8e45-2985609af173
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