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

Source: https://www.keypedia.com/records/483/optum-infusion-services-308-llc/9ab6ac46-4365-4855-b792-3dffeb66c2b0

> FDA 483 for Optum Infusion Services 308, LLC on March 18, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Optum Infusion Services 308, LLC
- Inspection Date: 2022-03-18
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: 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

## Related Officers

- [Investigator](https://www.keypedia.com/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)

Company: https://www.keypedia.com/companies/optum-infusion-services-308-llc/d772699a-55dd-4cba-a731-86c274593108

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b