Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2010-06-16.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jun 2010 | Not recorded | 483 | View 483 → |
| 15 Apr 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Jun 2010
21 CFR 211.22(a)
Lack of quality control unit
Cited by Kelly D Moore, Matthew R Dionne, Kevin D Kallander
16 Jun 2010
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Kelly D Moore, Matthew R Dionne, Kevin D Kallander
16 Jun 2010
21 CFR 211.28(a)
Clothing appropriate for duties performed
Cited by Kelly D Moore, Matthew R Dionne, Kevin D Kallander
16 Jun 2010
21 CFR 211.42(c)(5)
Mfg / Processing Operations Area
Cited by Kelly D Moore, Matthew R Dionne, Kevin D Kallander
16 Jun 2010
21 CFR 211.42(c)(10)(i)
Floors, walls, ceiling surfaces
Cited by Kelly D Moore, Matthew R Dionne, Kevin D Kallander
Investigators
FDA investigators tied to this site in the record.
Kelly D Moore2 insp.
Matthew R Dionne1 insp.
Kevin D Kallander1 insp.
Marc A Jackson1 insp.
Kimberley A Hoefen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.115(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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.11(h) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Regenerative Sciences, LLC's 2 Form 483s
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