US Compounding Inc.
Form 483 issued March 27, 2014 · Conway, Arkansas
- Inspection
- Mar 17 – Mar 27, 2014
- Investigators
- Erika V. Butler· Kimberley A. Hoefeo
- Observations
- 8
- Pages
- 4
- FEI number
- 3006031801
In short: On March 27, 2014, FDA issued a Form 483 with 8 observations to US Compounding Inc. in Conway, Arkansas (FEI 3006031801) after an inspection that ran Mar 17 – Mar 27, 2014. The investigators were Erika V. Butler and Kimberley A. Hoefeo. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Protective apparel is not worn as necessary to protect…
- 02
Procedures designed to prevent microbiological coniamination ofdrug products purporting to be…
- 03
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 04
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
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 211.28(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at US Compounding Inc.?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected US Compounding Inc.?
Erika V. Butler and Kimberley A. Hoefeo are named on this Form 483, for the inspection of Mar 17 – Mar 27, 2014. Each investigator has a profile showing what they cite most.
When was US Compounding Inc. inspected by FDA?
The inspection ran Mar 17 – Mar 27, 2014, and the Form 483 is dated March 27, 2014.
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.