Datascope Corp.
Form 483 issued January 21, 2022 · Wayne, New Jersey
- Inspection
- Nov 1, 2021 – Jan 21, 2022
- Investigators
- Claire L. Hambright· Colin E. Tack
- Observations
- 13
- Pages
- 15
- FEI number
- 3007965489
In short: On January 21, 2022, FDA issued a Form 483 with 13 observations to Datascope Corp. in Wayne, New Jersey (FEI 3007965489) after an inspection that ran Nov 1, 2021 – Jan 21, 2022. The investigators were Claire L. Hambright and Colin E. Tack. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and design controls account for 10 of 13 observations.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action…
- 02
Risk analysis was not…
- 03
Procedures for design validation…
- 04
Procedures for design verification…
This inspection in context
Claire L. Hambright
1 document · 2022
Cites 820.30(f) (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmDatascope Corp. history
The site's inspection history, in date order.
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 13 observations on this Form 483, mostly about cAPA, design controls and production & process controls. 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.?
Claire L. Hambright and Colin E. Tack are named on this Form 483, for the inspection of Nov 1, 2021 – Jan 21, 2022. Each investigator has a profile showing what they cite most.
When was Datascope Corp. inspected by FDA?
The inspection ran Nov 1, 2021 – Jan 21, 2022, and the Form 483 is dated January 21, 2022.
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.