JCB Labs LLC
Form 483 issued February 27, 2013 · Wichita, Kansas
- Inspection
- Feb 12 – Feb 27, 2013
- Investigators
- Janet B. Abt· Michael S. Kopf· Monica M. McClure
- Observations
- 4
- Pages
- 3
- FEI number
- 3004839646
In short: On February 27, 2013, FDA issued a Form 483 with 4 observations to JCB Labs LLC in Wichita, Kansas (FEI 3004839646) after an inspection that ran Feb 12 – Feb 27, 2013. The investigators were Janet B. Abt, Michael S. Kopf and Monica M. McClure. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Deviations from written production and process control procedures are…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Janet B. Abt
1 document · 2013
Cites 211.100(b) (written procedures; deviations) more than any other section. Most of their documents are for sites in Kansas.
The firmJCB Labs LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at JCB Labs LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected JCB Labs LLC?
Janet B. Abt, Michael S. Kopf and Monica M. McClure are named on this Form 483, for the inspection of Feb 12 – Feb 27, 2013. Each investigator has a profile showing what they cite most.
When was JCB Labs LLC inspected by FDA?
The inspection ran Feb 12 – Feb 27, 2013, and the Form 483 is dated February 27, 2013.
How do I get the full Form 483 for JCB Labs 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.