Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-10-03.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Jul 2018 – 3 Oct 2018 | Medical Devices & Rad Health | WL | View 483 → |
| 13 Apr 2010 | Not recorded | 483 | On file |
| 1 Apr 2010 | Not recorded | Clean | |
| 14 Jan 2008 | Not recorded | Clean | |
| 21 May 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Oct 2018
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Frank J Marciniak, Melissa A Zuppe
3 Oct 2018
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Frank J Marciniak, Melissa A Zuppe
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 | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Datascope Corp.'s 2 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