Datascope Corp.
FDA inspection history in Wayne, New Jersey, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Wayne, New Jersey.
Cited most
Across all Datascope observations on file
- 21 CFR 820.30(f)Design controls4
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 803.56If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?1
- 21 CFR 820.100(a)Corrective and preventive action1
The complete Datascope file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Wayne, New Jersey
One Form 483 · 2022 · 13 observations
Latest: Form 483, Jan 21, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-01-21 | 483 Form 483 | Wayne, New Jersey | 13 | $99 |
Investigators on these documents
FEI number 3007965489 · most recent document Jan 21, 2022
About Datascope Corp.
How many FDA Form 483s has Datascope Corp. received?
FDA Intel has 1 Form 483 on file for Datascope Corp.; the most recent is dated Jan 21, 2022.
When was Datascope Corp. last inspected by FDA?
The most recent FDA inspection document on file for Datascope Corp. is a Form 483 dated Jan 21, 2022, for the site in Wayne, New Jersey.
What did FDA cite at Datascope Corp.?
The regulations cited most in the observations on file for Datascope Corp. are 21 CFR 820.30(f) (Design controls), 4 times; 21 CFR 803.50(a)(1) (If I am a manufacturer, what reporting requirements apply to me?), 2 times; 21 CFR 820.198(a) (Complaint files), 2 times.