AbleNet
FDA inspection history in Roseville, Minnesota, 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 Roseville, Minnesota.
Cited most
Across all AbleNet observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.20(c)Management responsibility1
- 21 CFR 820.22Quality audit1
The complete AbleNet file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Roseville, Minnesota
One Form 483 · 2024 · 8 observations
Latest: Form 483, Jul 8, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-08 | 483 Form 483 | Roseville, Minnesota | 8 | $99 |
Investigators on these documents
FEI number 3001576173 · most recent document Jul 8, 2024
About AbleNet
How many FDA Form 483s has AbleNet received?
FDA Intel has 1 Form 483 on file for AbleNet; the most recent is dated Jul 8, 2024.
When was AbleNet last inspected by FDA?
The most recent FDA inspection document on file for AbleNet is a Form 483 dated Jul 8, 2024, for the site in Roseville, Minnesota.
What did FDA cite at AbleNet?
The regulations cited most in the observations on file for AbleNet are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time.