Optum Compounding Services, LLC
Form 483 issued August 13, 2021 · Phoenix, Arizona
- Inspection
- Aug 2 – Aug 13, 2021
- Investigators
- Darren S. Brown· Jeffrey P. Raimondi
- Observations
- 3
- Pages
- 5
- FEI number
- 3012890460
In short: On August 13, 2021, FDA issued a Form 483 with 3 observations to Optum Compounding Services, LLC in Phoenix, Arizona (FEI 3012890460) after an inspection that ran Aug 2 – Aug 13, 2021. The investigators were Darren S. Brown and Jeffrey P. Raimondi. Most observations concern quality system and materials.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Drug product containers or closures are additive so as to alter the safety, identity, strength, quality…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmOptum Compounding Services, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Optum Compounding Services, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system and materials. The opening words of each observation are shown on this page.
Who inspected Optum Compounding Services, LLC?
Darren S. Brown and Jeffrey P. Raimondi are named on this Form 483, for the inspection of Aug 2 – Aug 13, 2021. Each investigator has a profile showing what they cite most.
When was Optum Compounding Services, LLC inspected by FDA?
The inspection ran Aug 2 – Aug 13, 2021, and the Form 483 is dated August 13, 2021.
How do I get the full Form 483 for Optum Compounding Services, 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.