Wutek Orthopaedics, Inc
FDA inspection history in Fort Lauderdale, Florida, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Fort Lauderdale, Florida.
Cited most
Across all Wutek Orthopaedics observations on file
- 21 CFR 803.17(a)(1)What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.184Device history record1
- 21 CFR 820.20(c)Management responsibility1
- 21 CFR 820.22Quality audit1
- 21 CFR 820.25(b)Personnel1
The complete Wutek Orthopaedics file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Fort Lauderdale, Florida
One Form 483 · 2024 · 9 observations
Latest: Form 483, Nov 19, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-19 | 483 Form 483 | Fort Lauderdale, Florida | 9 | $99 |
Investigators on these documents
FEI number 3005893246 · most recent document Nov 19, 2024
About Wutek Orthopaedics, Inc
How many FDA Form 483s has Wutek Orthopaedics, Inc received?
FDA Intel has 1 Form 483 on file for Wutek Orthopaedics, Inc; the most recent is dated Nov 19, 2024.
When was Wutek Orthopaedics, Inc last inspected by FDA?
The most recent FDA inspection document on file for Wutek Orthopaedics, Inc is a Form 483 dated Nov 19, 2024, for the site in Fort Lauderdale, Florida.
What did FDA cite at Wutek Orthopaedics, Inc?
The regulations cited most in the observations on file for Wutek Orthopaedics, Inc are 21 CFR 803.17(a)(1) (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.184 (Device history record), 1 time; 21 CFR 820.20(c) (Management responsibility), 1 time.