Bergen Medical Products, Inc
Form 483 issued September 11, 2019 · Morris Plains, New Jersey
- Inspection
- Aug 27 – Sep 11, 2019
- Investigator
- Melissa A. Zuppe
- Observations
- 3
- Pages
- 4
- FEI number
- 3013449622
In short: On September 11, 2019, FDA issued a Form 483 with 3 observations to Bergen Medical Products, Inc in Morris Plains, New Jersey (FEI 3013449622) after an inspection that ran Aug 27 – Sep 11, 2019. The investigator was Melissa A. Zuppe. Most observations concern cAPA and design controls.
At a glance
CAPA and design controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Records of complamt mvestigations are not maintamed by…
- 02
The design history file…
- 03
Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at…
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 firmBergen Medical Products, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bergen Medical Products, Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA, design controls and management controls. The opening words of each observation are shown on this page.
Who inspected Bergen Medical Products, Inc?
Melissa A. Zuppe is named on this Form 483, for the inspection of Aug 27 – Sep 11, 2019. Each investigator has a profile showing what they cite most.
When was Bergen Medical Products, Inc inspected by FDA?
The inspection ran Aug 27 – Sep 11, 2019, and the Form 483 is dated September 11, 2019.
How do I get the full Form 483 for Bergen Medical Products, Inc?
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.