Optum Compounding Services, LLC
FDA inspection history across 2 sites, 2018 to 2021
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2018: one Form 483; 2021: one Form 483 and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Phoenix, Arizona.
- 2018The longest 483 on file: 4 observations over 4 pages at Phoenix, Arizona.
- 2021One Form 483 and one warning letter, at Phoenix, Arizona and Arizona.
Cited most
Across all Optum Compounding Services observations on file
- 21 CFR 211.22(c)Responsibilities of quality control unit2
- 21 CFR 211.142(b)Warehousing procedures1
- 21 CFR 211.192Production record review1
- 21 CFR 211.42(c)(10)(vi)Design and construction features1
- 21 CFR 211.94(a)Drug product containers and closures1
The complete Optum Compounding Services file.
All 3 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
Phoenix, Arizona
Two Form 483s · 2018 to 2021 · 7 observations
Latest: Form 483, Aug 13, 2021 →Arizona
One warning letter · 2021
Latest: Warning letter, Mar 31, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-08-13 | 483 Form 483 | Phoenix, Arizona | 3 | $99 |
| 2021-03-31 | Warning letter Warning letter | Arizona | — | $99 |
| 2018-04-20 | 483 Form 483 | Phoenix, Arizona | 4 | $99 |
Investigators on these documents
Darren S. Brown (1)Jeffrey P. Raimondi (1)Nayan J. Patel (1)Rumany C. Penn (1)
FEI number 3012890460 · most recent document Aug 13, 2021
About Optum Compounding Services, LLC
How many FDA Form 483s has Optum Compounding Services, LLC received?
FDA Intel has 2 Form 483s on file for Optum Compounding Services, LLC; the most recent is dated Aug 13, 2021.
When was Optum Compounding Services, LLC last inspected by FDA?
The most recent FDA inspection document on file for Optum Compounding Services, LLC is a Form 483 dated Aug 13, 2021, for the site in Phoenix, Arizona.
What did FDA cite at Optum Compounding Services, LLC?
The regulations cited most in the observations on file for Optum Compounding Services, LLC are 21 CFR 211.22(c) (Responsibilities of quality control unit), 2 times; 21 CFR 211.142(b) (Warehousing procedures), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Optum Compounding Services, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Optum Compounding Services, LLC; the most recent is dated Mar 31, 2021.