FDA 483 - Optum Infusion Services 308, LLC - March 18, 2022

This FDA Form 483 was issued to Optum Infusion Services 308, LLC, a producer of sterile drug products, located at 2555 W Fairview St Ste 104 Bldg D, Chandler, AZ, following an inspection from March 8-18, 2022. William J. Kottmer, General Manager, was the recipient.

Six observations were noted:

1. **Inadequate product evaluation for microbial contamination:** The firm failed to assess the impact on sterile drug products after finding bacterial/fungal growth (Brevibacterium, Micrococcus, Coagulase Negative Staphylococcus, Aspergillus, Alternaria, Paenibacillus species) in ISO-5 and ISO-7 areas on multiple dates (November 22, 2021; August 16, 2021; May 4, 2021). Products produced during these contamination periods were not evaluated for potential impact.

2. **Improper personnel aseptic technique:** Technicians were observed touching non-ISO 5 surfaces with gloved hands and then engaging in aseptic processing without sanitizing or changing gloves. Examples include opening sterile bags in ISO-7 and then touching the Direct Compounding Area in ISO-5 without re-sanitizing, and touching dirty mop pads then other surfaces without glove changes/sanitization.

3. **Exposed hair during aseptic processing:** Technicians