Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-07.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Dec 2023 – 7 Dec 2023 | Medical Devices & Rad Health | Clean | |
| 8 Oct 2019 – 10 Oct 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Sep 2016 – 8 Sep 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Apr 2013 – 10 Apr 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Jun 2010 | Not recorded | 483 | View 483 → |
| 16 Oct 2006 | Not recorded | Clean | |
| 20 Jun 2000 | Not recorded | Clean | |
| 27 Oct 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Sep 2016
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Richard K Vogel
8 Sep 2016
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Richard K Vogel
10 Apr 2013
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Richard K Vogel, Lisa A Warner
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind International Sterilization Laboratory, LLC'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