Datascope Corp.
FDA inspection history across 2 sites, 2018 to 2019
- 1
- Close-out
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2018: one Form 483 and one warning letter; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19One Form 483, one warning letter and one close-out letter, at Mahwah, New Jersey and Fairfield, New Jersey.
Cited most
Across all Datascope observations on file
- 21 CFR 820.30(f)Design controls3
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.184Device history record1
- 21 CFR 820.40(a)Document controls1
- 21 CFR 820.50(a)(1)Purchasing controls1
The complete Datascope file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Mahwah, New Jersey
One close-out letter and one Form 483 · 2018 to 2019 · 9 observations
Latest: Close-out, Feb 6, 2019 →Fairfield, New Jersey
One warning letter · 2018
Latest: Warning letter, Sep 11, 2018 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-02-06 | Close-out Close-out letter | Mahwah, New Jersey | — | $99 |
| 2018-10-03 | 483 Form 483 | Mahwah, New Jersey | 9 | $99 |
| 2018-09-11 | Warning letter Warning letter | Fairfield, New Jersey | — | $99 |
Investigators on these documents
FEI number 3001418283 · most recent document Feb 6, 2019
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 Oct 3, 2018.
When was Datascope Corp. last inspected by FDA?
The most recent FDA inspection document on file for Datascope Corp. is a Form 483 dated Oct 3, 2018, for the site in Mahwah, 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), 3 times; 21 CFR 820.100(a) (Corrective and preventive action), 2 times; 21 CFR 820.184 (Device history record), 1 time.
Has Datascope Corp. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Datascope Corp.; the most recent is dated Sep 11, 2018.