Kirkman Group, Inc
FDA inspection history in Lake Oswego, Oregon, 2015 to 2026
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2015: one Form 483; 2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Lake Oswego, Oregon.
- 2025–26One Form 483 and one warning letter, at Lake Oswego, Oregon.
- 2025The longest 483 on file: 8 observations over 8 pages at Lake Oswego, Oregon.
Cited most
Across all Kirkman Group observations on file
- 21 CFR 111.70(b)(2)What specifications must you establish?2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.122(b)Materials examination and usage criteria1
- 21 CFR 211.137(b)Expiration dating1
- 21 CFR 211.166(a)Stability testing1
The complete Kirkman Group file.
All 3 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
Lake Oswego, Oregon
Two Form 483s and one warning letter · 2015 to 2026 · 10 observations
Latest: Warning letter, Jan 27, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-01-27 | Warning letter Warning letter | Lake Oswego, Oregon | — | $99 |
| 2025-08-22 | 483 Form 483 | Lake Oswego, Oregon | 8 | $99 |
| 2015-07-15 | 483 Form 483 | Lake Oswego, Oregon | 2 | $99 |
Investigators on these documents
Anney Lin (1)Gerard P. De Leon (1)Nancy E. Byerly (1)Nathan E. Hellman (1)
FEI number 3004268965 · most recent document Jan 27, 2026
About Kirkman Group, Inc
How many FDA Form 483s has Kirkman Group, Inc received?
FDA Intel has 2 Form 483s on file for Kirkman Group, Inc; the most recent is dated Aug 22, 2025.
When was Kirkman Group, Inc last inspected by FDA?
The most recent FDA inspection document on file for Kirkman Group, Inc is a Form 483 dated Aug 22, 2025, for the site in Lake Oswego, Oregon.
What did FDA cite at Kirkman Group, Inc?
The regulations cited most in the observations on file for Kirkman Group, Inc are 21 CFR 111.70(b)(2) (What specifications must you establish?), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.122(b) (Materials examination and usage criteria), 1 time.
Has Kirkman Group, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Kirkman Group, Inc; the most recent is dated Jan 27, 2026.