MONOPRICE INC
FDA inspection history in Hebron, Kentucky, 2025
- 1
- Form 483
Every document, by year
- Form 483
2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One Form 483, at Hebron, Kentucky.
Cited most
Across all MONOPRICE 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 820.198(a)Complaint files1
The complete MONOPRICE file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Hebron, Kentucky
One Form 483 · 2025 · 2 observations
Latest: Form 483, Jul 2, 2025 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-02 | 483 Form 483 | Hebron, Kentucky | 2 | $99 |
Investigators on these documents
FEI number 3013973519 · most recent document Jul 2, 2025
About MONOPRICE INC
How many FDA Form 483s has MONOPRICE INC received?
FDA Intel has 1 Form 483 on file for MONOPRICE INC; the most recent is dated Jul 2, 2025.
When was MONOPRICE INC last inspected by FDA?
The most recent FDA inspection document on file for MONOPRICE INC is a Form 483 dated Jul 2, 2025, for the site in Hebron, Kentucky.
What did FDA cite at MONOPRICE INC?
The regulations cited most in the observations on file for MONOPRICE INC 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 820.198(a) (Complaint files), 1 time.