Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-09-19.
At a glance
Inspections
6
Form 483s
2
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Sep 2016 – 19 Sep 2016 | Human Drugs | Clean | |
| 6 Oct 2014 – 9 Oct 2014 | Human Drugs | 483 | View 483 → |
| 12 Apr 2012 | Not recorded | 483 | View 483 → |
| 9 Jun 2008 | Not recorded | Clean | |
| 2 Nov 2005 | Not recorded | Clean | |
| 12 Jul 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Oct 2014
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Steven P Donald, Alberto A Viciedo
9 Oct 2014
21 CFR 211.130(e)
Packaging line inspection before use
Cited by Steven P Donald, Alberto A Viciedo
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 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.134(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Blispak, 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