OurPharma LLC
Form 483 issued August 12, 2026 · Fayetteville, Arkansas
- Inspection
- Aug 3 – Aug 12, 2026
- Investigator
- Beatrix D. Hippe
- Observations
- 3
- Pages
- 8
- FEI number
- 3014064135
In short: On August 12, 2026, FDA issued a Form 483 with 3 observations to OurPharma LLC in Fayetteville, Arkansas (FEI 3014064135) after an inspection that ran Aug 3 – Aug 12, 2026. The investigator was Beatrix D. Hippe. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
- 03
Drug product production and control records, are not reviewed by the quality control unit to determine…
This inspection in context
Beatrix D. Hippe
4 documents · 2024–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OurPharma LLC?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected OurPharma LLC?
Beatrix D. Hippe is named on this Form 483, for the inspection of Aug 3 – Aug 12, 2026. Each investigator has a profile showing what they cite most.
When was OurPharma LLC inspected by FDA?
The inspection ran Aug 3 – Aug 12, 2026, and the Form 483 is dated August 12, 2026.
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.