Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-09-24.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Sep 2019 – 24 Sep 2019 | Human Drugs | 483 | View 483 → |
| 30 Jun 2014 | Human Drugs | Clean | |
| 24 Jul 2013 | Human Drugs | Clean | |
| 21 Feb 2010 | Not recorded | Clean | |
| 18 Aug 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jennifer A Longie Vollom4 insp.
Scott A Golladay1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Shalem Products Inc's 1 Form 483
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