Datascope Corp.
Form 483 issued October 3, 2018 · Mahwah, New Jersey
- Inspection
- Jul 30 – Oct 3, 2018
- Investigators
- Frank J. Marciniak· Melissa A. Zuppe
- Observations
- 9
- Pages
- 12
- FEI number
- 3001418283
In short: On October 3, 2018, FDA issued a Form 483 with 9 observations to Datascope Corp. in Mahwah, New Jersey (FEI 3001418283) after an inspection that ran Jul 30 – Oct 3, 2018. The investigators were Frank J. Marciniak and Melissa A. Zuppe. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and capa account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design validation…
- 02
Procedures for design change have…
- 03
Design verification does not confirm that design output…
- 04
Corrective and preventive action activities and/or results…
This inspection in context
Frank J. Marciniak
7 documents · 2018–2023
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmDatascope Corp. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Datascope Corp.?
FDA listed 9 observations on this Form 483, mostly about design controls, cAPA and records & documents. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Datascope Corp.?
Frank J. Marciniak and Melissa A. Zuppe are named on this Form 483, for the inspection of Jul 30 – Oct 3, 2018. Each investigator has a profile showing what they cite most.
When was Datascope Corp. inspected by FDA?
The inspection ran Jul 30 – Oct 3, 2018, and the Form 483 is dated October 3, 2018.
How do I get the full Form 483 for Datascope Corp.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.