Merit Medical Systems, Inc.
Form 483 issued September 12, 2015 · South Jordan, Utah
- Inspection
- Jul 16 – Sep 12, 2015
- Investigators
- Benjamin F. Torgersen· Teresa M. Ramey
- Observations
- 5
- Pages
- 13
- FEI number
- 1519862
In short: On September 12, 2015, FDA issued a Form 483 with 5 observations to Merit Medical Systems, Inc. in South Jordan, Utah (FEI 1519862) after an inspection that ran Jul 16 – Sep 12, 2015. The investigators were Benjamin F. Torgersen and Teresa M. Ramey. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 1 system, led by design controls.
Most cited: 21 CFR 820.30 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
SoSN papudlUl PUL SpIdU JaSN PULJop O} SULIOZUOD VOLASp OY} aiNsUd…
- 04
Design input requirements were…
This inspection in context
Benjamin F. Torgersen
1 document · 2015
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Utah.
The firmMerit Medical Systems, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merit Medical Systems, Inc.?
FDA listed 5 observations on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Merit Medical Systems, Inc.?
Benjamin F. Torgersen and Teresa M. Ramey are named on this Form 483, for the inspection of Jul 16 – Sep 12, 2015. Each investigator has a profile showing what they cite most.
When was Merit Medical Systems, Inc. inspected by FDA?
The inspection ran Jul 16 – Sep 12, 2015, and the Form 483 is dated September 12, 2015.
How do I get the full Form 483 for Merit Medical Systems, 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.