OurPharma LLC
Form 483 issued September 30, 2021 · Fayetteville, Arkansas
- Inspection
- Sep 20 – Sep 30, 2021
- Investigator
- Margaret M. Annes
- Observations
- 2
- Pages
- 3
- FEI number
- 3014064135
In short: On September 30, 2021, FDA issued a Form 483 with 2 observations to OurPharma LLC in Fayetteville, Arkansas (FEI 3014064135) after an inspection that ran Sep 20 – Sep 30, 2021. The investigator was Margaret M. Annes. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42(c)(10)(iv) (1×) · 211.42(c)(10)(v) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmOurPharma LLC history
All 2 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)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OurPharma LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. 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 OurPharma LLC?
Margaret M. Annes is named on this Form 483, for the inspection of Sep 20 – Sep 30, 2021. Each investigator has a profile showing what they cite most.
When was OurPharma LLC inspected by FDA?
The inspection ran Sep 20 – Sep 30, 2021, and the Form 483 is dated September 30, 2021.
How do I get the full Form 483 for OurPharma 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.