Zuga Medical Inc.
Form 483 issued January 27, 2017 · Beachwood, Ohio
- Inspection
- Jan 5 – Jan 27, 2017
- Investigator
- Laureen M. Geniusz
- Observations
- 1
- Pages
- 5
- FEI number
- 3010251542
In short: On January 27, 2017, FDA issued a Form 483 with 1 observation to Zuga Medical Inc. in Beachwood, Ohio (FEI 3010251542) after an inspection that ran Jan 5 – Jan 27, 2017. The investigator was Laureen M. Geniusz. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
This inspection in context
Laureen M. Geniusz
10 documents · 2015–2026
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Ohio.
The firmZuga Medical Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zuga Medical Inc.?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Zuga Medical Inc.?
Laureen M. Geniusz is named on this Form 483, for the inspection of Jan 5 – Jan 27, 2017. Each investigator has a profile showing what they cite most.
When was Zuga Medical Inc. inspected by FDA?
The inspection ran Jan 5 – Jan 27, 2017, and the Form 483 is dated January 27, 2017.
How do I get the full Form 483 for Zuga Medical 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.