Frantz Medical Development Ltd.
FDA inspection history in Mentor, Ohio, 2018 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Mentor, Ohio.
- 2018The longest 483 on file: 5 observations over 6 pages at Mentor, Ohio.
- 2023One Form 483, at Mentor, Ohio.
Cited most
Across all Frantz Medical Development observations on file
- 21 CFR 820.100(a)Corrective and preventive action3
- 21 CFR 820.75(b)Process validation2
- 21 CFR 820.90(a)Nonconforming product2
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.250(a)Statistical techniques1
The complete Frantz Medical Development file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Mentor, Ohio
Two Form 483s · 2018 to 2023 · 10 observations
Latest: Form 483, Jun 27, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-06-27 | 483 Form 483 | Mentor, Ohio | 5 | $99 |
| 2018-09-24 | 483 Form 483 | Mentor, Ohio | 5 | $99 |
Investigators on these documents
FEI number 1526605 · most recent document Jun 27, 2023
About Frantz Medical Development Ltd.
How many FDA Form 483s has Frantz Medical Development Ltd. received?
FDA Intel has 2 Form 483s on file for Frantz Medical Development Ltd.; the most recent is dated Jun 27, 2023.
When was Frantz Medical Development Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Frantz Medical Development Ltd. is a Form 483 dated Jun 27, 2023, for the site in Mentor, Ohio.
What did FDA cite at Frantz Medical Development Ltd.?
The regulations cited most in the observations on file for Frantz Medical Development Ltd. are 21 CFR 820.100(a) (Corrective and preventive action), 3 times; 21 CFR 820.75(b) (Process validation), 2 times; 21 CFR 820.90(a) (Nonconforming product), 2 times.