Ace Surgical Supply Co., Inc.
⚠️ Moderate Risk
FEI: 1287163 • Brockton, MA • UNITED STATES
FEI Number
1287163
Location
Brockton, MA
Country
UNITED STATESAddress
1034 Pearl St, , Brockton, 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 |
|---|---|---|---|
| 6/21/2011 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/21/2011 | 79KKXDRAPE, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/21/2011 | 79KCYTOURNIQUET, PNEUMATIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/21/2011 | 79GEMGAUZE, ABSORBABLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/21/2011 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/21/2011 | 79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/21/2011 | 81GIOTUBE, COLLECTION, CAPILLARY BLOOD | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ace Surgical Supply Co., Inc.'s FDA import refusal history?
Ace Surgical Supply Co., Inc. (FEI: 1287163) has 7 FDA import refusal record(s) in our database, spanning from 6/21/2011 to 6/21/2011.
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. Ace Surgical Supply Co., Inc.'s FEI number is 1287163.
What types of violations has Ace Surgical Supply Co., Inc. received?
Ace Surgical Supply Co., Inc. 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 Ace Surgical Supply Co., Inc. come from?
All FDA import refusal data for Ace Surgical Supply Co., Inc. 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.