Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-11-08.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Nov 2016 – 8 Nov 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Oct 2012 | Not recorded | 483 | View 483 → |
| 14 Sep 2010 | Not recorded | 483 | On file |
| 18 Dec 2008 | Not recorded | 483 | View 483 → |
| 31 May 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Nov 2016
21 CFR 820.50(a)(3)
Acceptable supplier records, inadequate records
Cited by Maressa L Mills, Wendy R Blame
8 Nov 2016
21 CFR 820.50(a)(3)
Acceptable supplier records, inadequate records
Cited by Maressa L Mills, Wendy R Blame
Investigators
FDA investigators tied to this site in the record.
Wendy R Blame4 insp.
Maressa L Mills1 insp.
Erica M Katherine1 insp.
Christophe L Boulmay1 insp.
Natasha N Mccants1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.181(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Howard Instruments Inc'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