JCB Labs LLC
Form 483 issued September 14, 2018 · Wichita, Kansas
- Inspection
- Aug 13 – Sep 14, 2018
- Investigators
- Michele Perry Williams· Norman K. Starks
- Observations
- 10
- Pages
- 12
- FEI number
- 3004839646
In short: On September 14, 2018, FDA issued a Form 483 with 10 observations to JCB Labs LLC in Wichita, Kansas (FEI 3004839646) after an inspection that ran Aug 13 – Sep 14, 2018. The investigators were Michele Perry Williams and Norman K. Starks. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no testing to assure that a drug product meets applicable standards of identity, strength…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Michele Perry Williams
22 documents · 2009–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at JCB Labs LLC?
FDA listed 10 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected JCB Labs LLC?
Michele Perry Williams and Norman K. Starks are named on this Form 483, for the inspection of Aug 13 – Sep 14, 2018. Each investigator has a profile showing what they cite most.
When was JCB Labs LLC inspected by FDA?
The inspection ran Aug 13 – Sep 14, 2018, and the Form 483 is dated September 14, 2018.
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.