US Compounding Inc.
Form 483 issued July 15, 2016 · Conway, Arkansas
- Inspection
- Jul 6 – Jul 15, 2016
- Investigators
- Massoud Motamed· Scott Ballard
- Observations
- 6
- Pages
- 6
- FEI number
- 3006031801
In short: On July 15, 2016, FDA issued a Form 483 with 6 observations to US Compounding Inc. in Conway, Arkansas (FEI 3006031801) after an inspection that ran Jul 6 – Jul 15, 2016. The investigators were Massoud Motamed and Scott Ballard. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
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…
- 04
The quality control unit lacks the responsibility and authority to reject all drug products. . ·.·…
- 05
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
- 06
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Massoud Motamed
20 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Texas.
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 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected US Compounding Inc.?
Massoud Motamed and Scott Ballard are named on this Form 483, for the inspection of Jul 6 – Jul 15, 2016. Each investigator has a profile showing what they cite most.
When was US Compounding Inc. inspected by FDA?
The inspection ran Jul 6 – Jul 15, 2016, and the Form 483 is dated July 15, 2016.
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.