US Compounding Inc.
Form 483 issued February 7, 2019 · Conway, Arizona
- Inspection
- Jan 23 – Feb 7, 2019
- Investigator
- June P. Page
- Observations
- 10
- Pages
- 10
- FEI number
- 3006031801
In short: On February 7, 2019, FDA issued a Form 483 with 10 observations to US Compounding Inc. in Conway, Arizona (FEI 3006031801) after an inspection that ran Jan 23 – Feb 7, 2019. The investigator was June P. Page. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. ****THIS IS A REPEAT…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Aseptic processing areas are deficient in that ceilings are not smooth and/or hard surfaces…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
June P. Page
30 documents · 2015–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at US Compounding Inc.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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.?
June P. Page is named on this Form 483, for the inspection of Jan 23 – Feb 7, 2019. Each investigator has a profile showing what they cite most.
When was US Compounding Inc. inspected by FDA?
The inspection ran Jan 23 – Feb 7, 2019, and the Form 483 is dated February 7, 2019.
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.