JCB Labs LLC
FDA inspection history in Wichita, Kansas, 2013 to 2018
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2013: one Form 483; 2014: one warning letter; 2015: one Form 483; 2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–15Two Form 483s and one warning letter, at Wichita, Kansas.
- 2018One Form 483, at Wichita, Kansas.
- 2018The longest 483 on file: 10 observations over 12 pages at Wichita, Kansas.
Cited most
Across all JCB Labs observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.192Production record review2
The complete JCB Labs file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Wichita, Kansas
Three Form 483s and one warning letter · 2013 to 2018 · 18 observations
Latest: Form 483, Sep 14, 2018 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-09-14 | 483 Form 483 | Wichita, Kansas | 10 | $99 |
| 2015-12-03 | 483 Form 483 | Wichita, Kansas | 4 | $99 |
| 2014-07-07 | Warning letter Warning letter | Wichita, Kansas | — | $99 |
| 2013-02-27 | 483 Form 483 | Wichita, Kansas | 4 | $99 |
Investigators on these documents
Brett R. Havranek (1)Carl A. Huffman (1)Janet B. Abt (1)Michael S. Kopf (1)Michele Perry Williams (1)Monica M. McClure (1)Norman K. Starks (1)
FEI number 3004839646 · most recent document Sep 14, 2018
About JCB Labs LLC
How many FDA Form 483s has JCB Labs LLC received?
FDA Intel has 3 Form 483s on file for JCB Labs LLC; the most recent is dated Sep 14, 2018.
When was JCB Labs LLC last inspected by FDA?
The most recent FDA inspection document on file for JCB Labs LLC is a Form 483 dated Sep 14, 2018, for the site in Wichita, Kansas.
What did FDA cite at JCB Labs LLC?
The regulations cited most in the observations on file for JCB Labs LLC are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.160 (General requirements), 2 times.
Has JCB Labs LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for JCB Labs LLC; the most recent is dated Jul 7, 2014.