MONOPRICE INC
Form 483 issued July 2, 2025 · Hebron, Kentucky
- Inspection
- Jun 30 – Jul 2, 2025
- Investigators
- Taimane J. Fisher· Taylor L. Carmon
- Observations
- 2
- Pages
- 4
- FEI number
- 3013973519
In short: On July 2, 2025, FDA issued a Form 483 with 2 observations to MONOPRICE INC in Hebron, Kentucky (FEI 3013973519) after an inspection that ran Jun 30 – Jul 2, 2025. The investigators were Taimane J. Fisher and Taylor L. Carmon. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(a) (1×) · 803.17 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 02
Written MDR procedures have not…
This inspection in context
Taimane J. Fisher
3 documents · 2020–2025
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Kentucky.
The firmMONOPRICE INC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MONOPRICE INC?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected MONOPRICE INC?
Taimane J. Fisher and Taylor L. Carmon are named on this Form 483, for the inspection of Jun 30 – Jul 2, 2025. Each investigator has a profile showing what they cite most.
When was MONOPRICE INC inspected by FDA?
The inspection ran Jun 30 – Jul 2, 2025, and the Form 483 is dated July 2, 2025.
How do I get the full Form 483 for MONOPRICE INC?
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.