Optum Infusion Services 308 LLC
FDA issued a warning letter to Optum Infusion Services 308 LLC (Chandler, AZ) following a March 2022 inspection that found serious insanitary conditions in its sterile compounding operations, including vermin in the production area, microbial contamination in the ISO 5 aseptic processing zone, and improper aseptic technique by operators. These conditions rendered the facility's sterile drug products adulterated under section 501(a)(2)(A) of the FDCA. FDA found the facility's corrective action responses inadequate due to missing supporting documentation and directed the firm to respond within 15 working days, warning that failure to comply could result in seizure or injunction.
Required actions (2)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most pharmacy / compounding sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker