Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-08-13.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Aug 2021 – 13 Aug 2021 | Biologics | Clean | |
| 14 Aug 2017 – 21 Aug 2017 | Biologics | Clean | |
| 22 Jul 2013 – 2 Aug 2013 | Biologics | 483 | View 483 → |
| 8 Jul 2013 – 12 Jul 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Jul 2012 | Not recorded | WL | View 483 → |
| 10 Aug 2011 | Not recorded | 483 | View 483 → |
| 23 Apr 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jul 2012
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Stephen R Souza, James D Hildreth, Lauren E Swantko, Alexander M Kay
26 Jul 2012
21 CFR 820.40(a)
Not approved or obsolete document retrieval
Cited by Stephen R Souza, James D Hildreth, Lauren E Swantko, Alexander M Kay
Investigators
FDA investigators tied to this site in the record.
James D Hildreth2 insp.
Alexander M Kay2 insp.
Peter S Kessler1 insp.
Kathryn A Krentz1 insp.
Julian C Hanson1 insp.
Stephen R Souza1 insp.
Lauren E Swantko1 insp.
Mark W Babbitt1 insp.
Dan G Eisenbrey1 insp.
Dolores E Price1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.190(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.140 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bacterin International, Inc.'s 4 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