Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-02-07.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2020 – 7 Feb 2020 | Human Drugs | 483 | View 483 → |
| 15 Oct 2018 – 18 Oct 2018 | Human Drugs | 483 | On file |
| 20 Aug 2018 – 24 Aug 2018 | Human Drugs | 483 | View 483 → |
| 20 Jun 2016 – 24 Jun 2016 | Human Drugs | Clean | |
| 14 Oct 2013 – 18 Oct 2013 | Human Drugs | 483 | View 483 → |
| 2 Dec 2011 | Not recorded | Clean | |
| 21 Nov 2008 | Not recorded | 483 | On file |
| 7 Dec 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Aug 2018
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Rachael L Cook, Nije A Thomas
24 Aug 2018
21 CFR 211.110(a)
Written in-process control procedures
Cited by Rachael L Cook, Nije A Thomas
Investigators
FDA investigators tied to this site in the record.
Nicole E Knowlton1 insp.
Yvins Dezan1 insp.
Rachael L Cook1 insp.
Nije A Thomas1 insp.
Jose M Cayuela1 insp.
Robert C Horan1 insp.
Matthew B Casale1 insp.
William A Warnick1 insp.
Luis A Dasta1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind J.B. Chemicals & Pharmaceuticals Ltd's 5 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat