Birchwood Laboratories, LLC
FDA inspection history in Eden Prairie, Minnesota, 2022 to 2026
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Eden Prairie, Minnesota.
- 2022The longest 483 on file: 4 observations over 6 pages at Eden Prairie, Minnesota.
- 2026One Form 483, at Eden Prairie, Minnesota.
Cited most
Across all Birchwood Laboratories observations on file
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment2
- 21 CFR 211.166(a)(3)Stability testing1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.56(a)Sanitation1
- 21 CFR 211.67(a)Equipment cleaning and maintenance1
The complete Birchwood Laboratories file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Eden Prairie, Minnesota
Two Form 483s · 2022 to 2026 · 6 observations
Latest: Form 483, Feb 13, 2026 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-02-13 | 483 Form 483 | Eden Prairie, Minnesota | 2 | $99 |
| 2022-08-19 | 483 Form 483 | Eden Prairie, Minnesota | 4 | $99 |
Investigators on these documents
FEI number 2182825 · most recent document Feb 13, 2026
About Birchwood Laboratories, LLC
How many FDA Form 483s has Birchwood Laboratories, LLC received?
FDA Intel has 2 Form 483s on file for Birchwood Laboratories, LLC; the most recent is dated Feb 13, 2026.
When was Birchwood Laboratories, LLC last inspected by FDA?
The most recent FDA inspection document on file for Birchwood Laboratories, LLC is a Form 483 dated Feb 13, 2026, for the site in Eden Prairie, Minnesota.
What did FDA cite at Birchwood Laboratories, LLC?
The regulations cited most in the observations on file for Birchwood Laboratories, LLC are 21 CFR 211.68(b) (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.166(a)(3) (Stability testing), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.