Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-08.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Dec 2023 – 8 Dec 2023 | Human Drugs | 483 | View 483 → |
| 11 Apr 2016 – 12 Apr 2016 | Medical Devices & Rad Health | Clean | |
| 2 Dec 2014 – 3 Dec 2014 | Human Drugs | Clean | |
| 30 Mar 2012 | Not recorded | Clean | |
| 12 May 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Dec 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Claudia M Perez-Kasmarski
12 May 2011
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Sarah A Hassas, Maxyne T Lam
Investigators
FDA investigators tied to this site in the record.
Claudia M Perez-Kasmarski1 insp.
Cntrctmntr Anderson1 insp.
Matthew J Johnson1 insp.
Thao T Kwan1 insp.
Sarah A Hassas1 insp.
Maxyne T Lam1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.134(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Innovation Specialties, Inc.'s 2 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