Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-30.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Nov 2023 – 30 Nov 2023 | Human Drugs | 483 | View 483 → |
| 15 Dec 2022 – 22 Dec 2022 | Human Drugs | WL | View 483 → |
| 17 Apr 2018 – 21 May 2018 | Human Drugs | 483 | View 483 → |
| 20 Feb 2018 – 27 Feb 2018 | Human Drugs | 483 | View 483 → |
| 21 Sep 2015 – 25 Sep 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Apr 2014 – 25 Apr 2014 | Human Drugs | 483 | View 483 → |
| 9 Jun 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Nov 2023
21 CFR 211.166(a)
Results not used for expiration dates, storage cond.
Cited by Saied A Asbagh
Investigators
FDA investigators tied to this site in the record.
Saied A Asbagh1 insp.
Matthew R Clabeaux1 insp.
Uttaniti Limchumroon1 insp.
Stephanie A Slater1 insp.
Christopher D Washington1 insp.
Richmond K Yip1 insp.
Rafael A Kaup1 insp.
Diane C Van Leeuwen1 insp.
Cntrctmntr Kelley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Health Specialty'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