US Compounding Inc.
Form 483 issued August 21, 2015 · Conway, Arkansas
- Inspection
- Aug 10 – Aug 21, 2015
- Investigators
- Lloyd D. Payne· Massoud Motamed
- Observations
- 11
- Pages
- 11
- FEI number
- 3006031801
In short: On August 21, 2015, FDA issued a Form 483 with 11 observations to US Compounding Inc. in Conway, Arkansas (FEI 3006031801) after an inspection that ran Aug 10 – Aug 21, 2015. The investigators were Lloyd D. Payne and Massoud Motamed. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 7 of 11 observations.
Most cited: 21 CFR 211.42 (3×) · 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Lloyd D. Payne
3 documents · 2015
Cites 110.80 (processes and controls) more than any other section. Most of their documents are for sites in Oklahoma.
The firmUS Compounding Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at US Compounding Inc.?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected US Compounding Inc.?
Lloyd D. Payne and Massoud Motamed are named on this Form 483, for the inspection of Aug 10 – Aug 21, 2015. Each investigator has a profile showing what they cite most.
When was US Compounding Inc. inspected by FDA?
The inspection ran Aug 10 – Aug 21, 2015, and the Form 483 is dated August 21, 2015.
How do I get the full Form 483 for US Compounding Inc.?
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.