FDA 483 - Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy - December 17, 2019

This FDA Form 483 documents observations from an inspection of Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy, a producer of sterile and non-sterile drugs, located at 1826 Boy Scout Dr, Fort Myers, FL. The inspection occurred from December 9-17, 2019.

Key observations include:

1. **Personnel Contact with Sterile Surfaces:** An operator was observed manually contacting the inner surface of containers or closures with gloved fingers within an ISO 5 laminar airflow workbench (LAFW) during Trimix production. This was also noted in dynamic smoke studies. 2. **Inadequate Product Evaluation for Microbial Contamination:** The firm failed to adequately evaluate and take remedial action after actionable microbial contamination (Aspergillus versicolor) was found in areas adjacent to the ISO 5 aseptic processing area. Specifically, 1 cfu/m3 was found in the Compounding Room on September 30, 2019, and 1 cfu on a settle plate in the AnteRoom on November 11, 2019. The firm did not retest after cleaning on November 19, 2019, or assess the impact on drugs produced between September 30 and November 18, 2019. 3. **Lack of Procedures to Prevent Insanitary Conditions:** * No endotoxin testing was performed