Optum Compounding Services, LLC
Form 483 issued April 20, 2018 · Phoenix, Arizona
- Inspection
- Apr 9 – Apr 20, 2018
- Investigators
- Nayan J. Patel· Rumany C. Penn
- Observations
- 4
- Pages
- 4
- FEI number
- 3012890460
In short: On April 20, 2018, FDA issued a Form 483 with 4 observations to Optum Compounding Services, LLC in Phoenix, Arizona (FEI 3012890460) after an inspection that ran Apr 9 – Apr 20, 2018. The investigators were Nayan J. Patel and Rumany C. Penn. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 3 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity…
- 04FDCA 503B(a)(10)
The labels of your outsourcing facility's…
This inspection in context
Nayan J. Patel
11 documents · 2017–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Utah.
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 211.42(c)(10)(vi)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Optum Compounding Services, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Optum Compounding Services, LLC?
Nayan J. Patel and Rumany C. Penn are named on this Form 483, for the inspection of Apr 9 – Apr 20, 2018. Each investigator has a profile showing what they cite most.
When was Optum Compounding Services, LLC inspected by FDA?
The inspection ran Apr 9 – Apr 20, 2018, and the Form 483 is dated April 20, 2018.
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.