OrthoPediatrics Corp

⚠️ Moderate Risk

FEI: 3006460162 • Warsaw, IN • UNITED STATES

FEI

FEI Number

3006460162

📍

Location

Warsaw, IN

🇺🇸

Country

UNITED STATES

🏢

Address

2850 Frontier Dr, , Warsaw, IN, United States

Moderate Risk

FDA Import Risk Assessment

38.7

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

6/3/2019

Latest Refusal

6/3/2019

Earliest Refusal

Score Breakdown

Violation Severity

40.0×40%

Refusal Volume

42.5×30%

Recency

0.0×20%

Frequency

100.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

328013×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

34113×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

Date	Product	Violations	Division
6/3/2019	87HRSPLATE, FIXATION, BONE	3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
6/3/2019	87HRSPLATE, FIXATION, BONE	3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
6/3/2019	87HRSPLATE, FIXATION, BONE	3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
6/3/2019	87HRSPLATE, FIXATION, BONE	3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
6/3/2019	87HRSPLATE, FIXATION, BONE	3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
6/3/2019	87HRSPLATE, FIXATION, BONE	3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
6/3/2019	87HRSPLATE, FIXATION, BONE	3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
6/3/2019	87HRSPLATE, FIXATION, BONE	3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
6/3/2019	87HWCSCREW, FIXATION, BONE	3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
6/3/2019	87HWCSCREW, FIXATION, BONE	3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
6/3/2019	87HWCSCREW, FIXATION, BONE	3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
6/3/2019	87HWCSCREW, FIXATION, BONE	3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
6/3/2019	87HWCSCREW, FIXATION, BONE	3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is OrthoPediatrics Corp's FDA import refusal history?

OrthoPediatrics Corp (FEI: 3006460162) has 13 FDA import refusal record(s) in our database, spanning from 6/3/2019 to 6/3/2019.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. OrthoPediatrics Corp's FEI number is 3006460162.

What types of violations has OrthoPediatrics Corp received?

OrthoPediatrics Corp has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about OrthoPediatrics Corp come from?

All FDA import refusal data for OrthoPediatrics Corp is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.