Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-09-12.
At a glance
Inspections
8
Form 483s
6
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Sep 2019 – 12 Sep 2019 | Human Drugs | Clean | |
| 18 Oct 2018 – 26 Oct 2018 | Human Drugs | Clean | |
| 20 Oct 2016 – 31 Oct 2016 | Human Drugs | 483 | View 483 → |
| 15 Oct 2014 – 22 Oct 2014 | Human Drugs | 483 | On file |
| 10 Jan 2013 | Not recorded | 483 | View 483 → |
| 7 Oct 2011 | Not recorded | 483 | View 483 → |
| 16 Aug 2011 | Not recorded | 483 | View 483 → |
| 23 Apr 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Oct 2016
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Robert J Martin
31 Oct 2016
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Robert J Martin
Investigators
FDA investigators tied to this site in the record.
Edmund F Mrak3 insp.
Robert J Martin3 insp.
Ramon E Martinez1 insp.
Matthew D Silverman1 insp.
Rory Geyer1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bio-Concept Laboratories, Inc's 6 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