Optum Infusion Services 308, LLC
FDA inspection history in Chandler, Arizona, 2022
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2022: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One warning letter and one Form 483, at Chandler, Arizona.
Cited most
Across all Optum Infusion Services 308 observations on file
- 21 CFR 211.56Sanitation2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.28Personnel responsibilities1
- 21 CFR 211.42Design and construction features1
The complete Optum Infusion Services 308 file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Chandler, Arizona
One warning letter and one Form 483 · 2022 · 6 observations
Latest: Warning letter, Dec 13, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-13 | Warning letter Warning letter | Chandler, Arizona | — | $99 |
| 2022-03-18 | 483 Form 483 | Chandler, Arizona | 6 | $99 |
Investigators on these documents
FEI number 3017600845 · most recent document Dec 13, 2022
About Optum Infusion Services 308, LLC
How many FDA Form 483s has Optum Infusion Services 308, LLC received?
FDA Intel has 1 Form 483 on file for Optum Infusion Services 308, LLC; the most recent is dated Mar 18, 2022.
When was Optum Infusion Services 308, LLC last inspected by FDA?
The most recent FDA inspection document on file for Optum Infusion Services 308, LLC is a Form 483 dated Mar 18, 2022, for the site in Chandler, Arizona.
What did FDA cite at Optum Infusion Services 308, LLC?
The regulations cited most in the observations on file for Optum Infusion Services 308, LLC are 21 CFR 211.56 (Sanitation), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Optum Infusion Services 308, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Optum Infusion Services 308, LLC; the most recent is dated Dec 13, 2022.