JCB Labs LLC
Form 483 issued December 3, 2015 · Wichita, Kansas
- Inspection
- Nov 16, 2015
- Investigators
- Brett R. Havranek· Carl A. Huffman
- Observations
- 4
- Pages
- 5
- FEI number
- 3004839646
In short: On December 3, 2015, FDA issued a Form 483 with 4 observations to JCB Labs LLC in Wichita, Kansas (FEI 3004839646) after an inspection that ran Nov 16, 2015. The investigators were Brett R. Havranek and Carl A. Huffman. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
The master production and control records are deficient in that they do not include complete manufacturing…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Brett R. Havranek
6 documents · 2015–2018
Cites 211.192 (production record review) 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
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, production and quality system. The opening words of each observation are shown on this page.
Who inspected JCB Labs LLC?
Brett R. Havranek and Carl A. Huffman are named on this Form 483, for the inspection of Nov 16, 2015. Each investigator has a profile showing what they cite most.
When was JCB Labs LLC inspected by FDA?
The inspection ran Nov 16, 2015, and the Form 483 is dated December 3, 2015.
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.