OurPharma LLC
Form 483 issued September 27, 2024 · Fayetteville, Arkansas
- Inspection
- Sep 16 – Sep 27, 2024
- Investigator
- Margaret M. Annes
- Observations
- 5
- Pages
- 6
- FEI number
- 301406135
In short: On September 27, 2024, FDA issued a Form 483 with 5 observations to OurPharma LLC in Fayetteville, Arkansas (FEI 301406135) after an inspection that ran Sep 16 – Sep 27, 2024. The investigator was Margaret M. Annes. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 2 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 03FDCA 503B(a)(10)(A)
Observation 3: scanned text, readable in the full document.
- 04FDCA 503B(a)(10)(B)
Observation 4: scanned text, readable in the full document.
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
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OurPharma LLC?
FDA listed 5 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). 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 16 – Sep 27, 2024. Each investigator has a profile showing what they cite most.
When was OurPharma LLC inspected by FDA?
The inspection ran Sep 16 – Sep 27, 2024, and the Form 483 is dated September 27, 2024.
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.