Cardio Medical Products
FDA inspection history in Rockaway, New Jersey, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Rockaway, New Jersey.
Cited most
Across all Cardio Medical Products observations on file
- 21 CFR 820.20(b)(3)Management responsibility2
- 21 CFR 820.30(a)Design controls2
- 21 CFR 8201
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
The complete Cardio Medical Products file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Rockaway, New Jersey
One Form 483 · 2019 · 10 observations
Latest: Form 483, Nov 5, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-11-05 | 483 Form 483 | Rockaway, New Jersey | 10 | $99 |
Investigators on these documents
FEI number 2246340 · most recent document Nov 5, 2019
About Cardio Medical Products
How many FDA Form 483s has Cardio Medical Products received?
FDA Intel has 1 Form 483 on file for Cardio Medical Products; the most recent is dated Nov 5, 2019.
When was Cardio Medical Products last inspected by FDA?
The most recent FDA inspection document on file for Cardio Medical Products is a Form 483 dated Nov 5, 2019, for the site in Rockaway, New Jersey.
What did FDA cite at Cardio Medical Products?
The regulations cited most in the observations on file for Cardio Medical Products are 21 CFR 820.20(b)(3) (Management responsibility), 2 times; 21 CFR 820.30(a) (Design controls), 2 times; 21 CFR 820, 1 time.