Overview
- 8 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-07-14.
At a glance
Inspections
8
Form 483s
1
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Jul 2022 – 14 Jul 2022 | Biologics | Clean | |
| 16 Jul 2019 – 19 Jul 2019 | Biologics | Clean | |
| 7 Nov 2016 – 14 Nov 2016 | Biologics | Clean | |
| 20 Oct 2014 – 23 Oct 2014 | Biologics | Clean | |
| 18 Oct 2012 | Not recorded | 483 | View 483 → |
| 4 Nov 2010 | Not recorded | Clean | |
| 1 Oct 2008 | Not recorded | Clean | |
| 13 May 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Oct 2012
21 CFR 1271.160(b)(5)
Monitoring systems
Cited by Juanita P Versace, Ann-Marie Karnick, Kimberly A Dux, Eufemia G Gonzalez
18 Oct 2012
21 CFR 1271.180(a)
Procedures to meet core CTGP
Cited by Juanita P Versace, Ann-Marie Karnick, Kimberly A Dux, Eufemia G Gonzalez
18 Oct 2012
21 CFR 1271.195(c)
Monitoring--cross contamination, exposure to CD
Cited by Juanita P Versace, Ann-Marie Karnick, Kimberly A Dux, Eufemia G Gonzalez
Investigators
FDA investigators tied to this site in the record.
Cara M Minelli3 insp.
Ann-Marie Karnick3 insp.
Kimberly A Dux3 insp.
Bradley E Benasutti2 insp.
Carl E Lovrich1 insp.
Emily A Walters1 insp.
Amanda B Athey1 insp.
Amanda B Vega1 insp.
Brian S Keefer1 insp.
Kip J Hanks1 insp.
Juanita P Versace1 insp.
Eufemia G Gonzalez1 insp.
Michele M Falchek1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.160(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Musculoskeletal Transplant Foundation, Inc.'s 1 Form 483
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