Frantz Medical Development Ltd.
Form 483 issued September 24, 2018 · Mentor, Ohio
- Inspection
- Sep 14 – Sep 24, 2018
- Investigator
- Laureen M. Geniusz
- Observations
- 5
- Pages
- 6
- FEI number
- 1526605
In short: On September 24, 2018, FDA issued a Form 483 with 5 observations to Frantz Medical Development Ltd. in Mentor, Ohio (FEI 1526605) after an inspection that ran Sep 14 – Sep 24, 2018. The investigator was Laureen M. Geniusz. Most observations concern cAPA and production & process controls.
At a glance
3 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Procedures have not been adequately established to control product that does not…
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
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 firmFrantz Medical Development Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Frantz Medical Development Ltd.?
FDA listed 5 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Frantz Medical Development Ltd.?
Laureen M. Geniusz is named on this Form 483, for the inspection of Sep 14 – Sep 24, 2018. Each investigator has a profile showing what they cite most.
When was Frantz Medical Development Ltd. inspected by FDA?
The inspection ran Sep 14 – Sep 24, 2018, and the Form 483 is dated September 24, 2018.
How do I get the full Form 483 for Frantz Medical Development Ltd.?
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.