Optum Infusion Services 308, LLC
Form 483 issued March 18, 2022 · Chandler, Arizona
- Inspection
- Mar 8 – Mar 18, 2022
- Investigator
- Truong X. Nguyen
- Observations
- 6
- Pages
- 5
- FEI number
- 3017600845
In short: On March 18, 2022, FDA issued a Form 483 with 6 observations to Optum Infusion Services 308, LLC in Chandler, Arizona (FEI 3017600845) after an inspection that ran Mar 8 – Mar 18, 2022. The investigator was Truong X. Nguyen. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Facilities & equipment and production account for 5 of 6 observations.
Most cited: 21 CFR 211.56 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 02
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area…
- 03
Personnel engaged in aseptic processing were…
- 04
The ISO 5 classified aseptic processing areas had…
This inspection in context
Truong X. Nguyen
20 documents · 2011–2026
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmOptum Infusion Services 308, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.56
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Optum Infusion Services 308, LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected Optum Infusion Services 308, LLC?
Truong X. Nguyen is named on this Form 483, for the inspection of Mar 8 – Mar 18, 2022. Each investigator has a profile showing what they cite most.
When was Optum Infusion Services 308, LLC inspected by FDA?
The inspection ran Mar 8 – Mar 18, 2022, and the Form 483 is dated March 18, 2022.
How do I get the full Form 483 for Optum Infusion Services 308, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.