DePuy Mitek, Inc., a Johnson & Johnson Co.
⚠️ Moderate Risk
FEI: 1221934 • Norwood, MA • UNITED STATES
FEI Number
1221934
Location
Norwood, MA
Country
UNITED STATESAddress
249 Vanderbilt Ave, , Norwood, MA, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/7/2011 | 87NBHACCESSORIES, ARTHROSCOPIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/7/2011 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/7/2011 | 87NBHACCESSORIES, ARTHROSCOPIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/7/2011 | 79GEFAPPLIER, STAPLE, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/11/2008 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is DePuy Mitek, Inc., a Johnson & Johnson Co.'s FDA import refusal history?
DePuy Mitek, Inc., a Johnson & Johnson Co. (FEI: 1221934) has 5 FDA import refusal record(s) in our database, spanning from 12/11/2008 to 12/7/2011.
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. DePuy Mitek, Inc., a Johnson & Johnson Co.'s FEI number is 1221934.
What types of violations has DePuy Mitek, Inc., a Johnson & Johnson Co. received?
DePuy Mitek, Inc., a Johnson & Johnson Co. has been cited for 1 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 DePuy Mitek, Inc., a Johnson & Johnson Co. come from?
All FDA import refusal data for DePuy Mitek, Inc., a Johnson & Johnson Co. 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.