Kirkman Group, Inc
Form 483 issued August 22, 2025 · Lake Oswego, Oregon
- Inspection
- Aug 18 – Aug 22, 2025
- Investigators
- Anney Lin· Nathan E. Hellman
- Observations
- 8
- Pages
- 8
- FEI number
- 3004268965
In short: On August 22, 2025, FDA issued a Form 483 with 8 observations to Kirkman Group, Inc in Lake Oswego, Oregon (FEI 3004268965) after an inspection that ran Aug 18 – Aug 22, 2025. The investigators were Anney Lin and Nathan E. Hellman. Most observations concern quality system and packaging & labeling.
At a glance
Quality system and packaging & labeling account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Written procedures are not established and followed for evaluations done at least annually and including provisions…
- 04
The written stability testing…
This inspection in context
Anney Lin
9 documents · 2023–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmKirkman Group, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kirkman Group, Inc?
FDA listed 8 observations on this Form 483, mostly about quality system, packaging & labeling and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Kirkman Group, Inc?
Anney Lin and Nathan E. Hellman are named on this Form 483, for the inspection of Aug 18 – Aug 22, 2025. Each investigator has a profile showing what they cite most.
When was Kirkman Group, Inc inspected by FDA?
The inspection ran Aug 18 – Aug 22, 2025, and the Form 483 is dated August 22, 2025.
How do I get the full Form 483 for Kirkman Group, Inc?
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.