Birchwood Laboratories, LLC
Form 483 issued February 13, 2026 · Eden Prairie, Minnesota
- Inspection
- Feb 9 – Feb 13, 2026
- Investigator
- Beatrix D. Hippe
- Observations
- 2
- Pages
- 3
- FEI number
- 2182825
In short: On February 13, 2026, FDA issued a Form 483 with 2 observations to Birchwood Laboratories, LLC in Eden Prairie, Minnesota (FEI 2182825) after an inspection that ran Feb 9 – Feb 13, 2026. The investigator was Beatrix D. Hippe. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.68(b) (1×) · 211.166(a)(3) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
The written stability program for drug products does not…
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 firmBirchwood Laboratories, 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 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Birchwood Laboratories, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Birchwood Laboratories, LLC?
Beatrix D. Hippe is named on this Form 483, for the inspection of Feb 9 – Feb 13, 2026. Each investigator has a profile showing what they cite most.
When was Birchwood Laboratories, LLC inspected by FDA?
The inspection ran Feb 9 – Feb 13, 2026, and the Form 483 is dated February 13, 2026.
How do I get the full Form 483 for Birchwood Laboratories, 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.