Frantz Medical Development Ltd.
Form 483 issued June 27, 2023 · Mentor, Ohio
- Inspection
- Jun 13 – Jun 27, 2023
- Investigator
- Laureen M. Geniusz
- Observations
- 5
- Pages
- 5
- FEI number
- 1526605
In short: On June 27, 2023, FDA issued a Form 483 with 5 observations to Frantz Medical Development Ltd. in Mentor, Ohio (FEI 1526605) after an inspection that ran Jun 13 – Jun 27, 2023. The investigator was Laureen M. Geniusz. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
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
Corrective and preventive action activities and/or results have…
- 03
Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process…
- 04
Procedures for rework of nonconforming product…
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 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 Frantz Medical Development Ltd.?
Laureen M. Geniusz is named on this Form 483, for the inspection of Jun 13 – Jun 27, 2023. Each investigator has a profile showing what they cite most.
When was Frantz Medical Development Ltd. inspected by FDA?
The inspection ran Jun 13 – Jun 27, 2023, and the Form 483 is dated June 27, 2023.
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.