Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-08-11.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Aug 2015 – 11 Aug 2015 | Medical Devices & Rad Health | 483 | On file |
| 4 Feb 2013 | Not recorded | 483 | View 483 → |
| 31 Jan 2011 | Not recorded | Clean | |
| 21 Jan 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Feb 2013
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Kwong P Lee
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 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Parkell, Inc.'s 2 Form 483s
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