Cardio Medical Products
Form 483 issued November 5, 2019 · Rockaway, New Jersey
- Inspection
- Oct 16 – Nov 5, 2019
- Investigator
- Melissa A. Zuppe
- Observations
- 10
- Pages
- 8
- FEI number
- 2246340
In short: On November 5, 2019, FDA issued a Form 483 with 10 observations to Cardio Medical Products in Rockaway, New Jersey (FEI 2246340) after an inspection that ran Oct 16 – Nov 5, 2019. The investigator was Melissa A. Zuppe. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and management controls account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Procedures for corrective and preventive action have…
- 03
Procedures for design control…
- 0421 CFR 820.30(j)21 CFR 820
The design history file does not demonstrate that the design was developed following the requirements…
This inspection in context
Melissa A. Zuppe
4 documents · 2018–2019
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmCardio Medical Products history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cardio Medical Products?
FDA listed 10 observations on this Form 483, mostly about cAPA, management controls and design 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 Cardio Medical Products?
Melissa A. Zuppe is named on this Form 483, for the inspection of Oct 16 – Nov 5, 2019. Each investigator has a profile showing what they cite most.
When was Cardio Medical Products inspected by FDA?
The inspection ran Oct 16 – Nov 5, 2019, and the Form 483 is dated November 5, 2019.
How do I get the full Form 483 for Cardio Medical Products?
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.