Kirkman Group, Inc
Form 483 issued July 15, 2015 · Lake Oswego, Oregon
- Inspection
- Jul 6 – Jul 15, 2015
- Investigators
- Gerard P. De Leon· Nancy E. Byerly
- Observations
- 2
- Pages
- 2
- FEI number
- 3004268965
In short: On July 15, 2015, FDA issued a Form 483 with 2 observations to Kirkman Group, Inc in Lake Oswego, Oregon (FEI 3004268965) after an inspection that ran Jul 6 – Jul 15, 2015. The investigators were Gerard P. De Leon and Nancy E. Byerly. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.70 (what specifications must you establish?).
At a glance
2 of 2 observations on this 483 concern dietary supplement cgmp.
Most cited: 21 CFR 111.70(b)(2) (1×) · 111.70(e) (1×)
What FDA observed
Preview: the opening words of each observation- 01
You did not establish component specifications…
- 02
You did not establish product specifications for the purity arid strength of…
This inspection in context
Gerard P. De Leon
9 documents · 2015–2017
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
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 111.70(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kirkman Group, Inc?
FDA listed 2 observations on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.70 (what specifications must you establish?). The opening words of each observation are shown on this page.
Who inspected Kirkman Group, Inc?
Gerard P. De Leon and Nancy E. Byerly are named on this Form 483, for the inspection of Jul 6 – Jul 15, 2015. Each investigator has a profile showing what they cite most.
When was Kirkman Group, Inc inspected by FDA?
The inspection ran Jul 6 – Jul 15, 2015, and the Form 483 is dated July 15, 2015.
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.