APC Medical, Ltd.
⚠️ Moderate Risk
FEI: 3002806386 • Welwyn Garden City, Hertfordshire • UNITED KINGDOM
FEI Number
3002806386
Location
Welwyn Garden City, Hertfordshire
Country
UNITED KINGDOMAddress
68 Tewin Rd, , Welwyn Garden City, Hertfordshire, United Kingdom
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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/30/2012 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 8/6/2012 | 74DTEPULSE-GENERATOR, PACEMAKER, EXTERNAL | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 8/6/2012 | 74JOQGENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 6/2/2010 | 74DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) | 290DE IMP GMP | New York District Office (NYK-DO) |
Frequently Asked Questions
What is APC Medical, Ltd.'s FDA import refusal history?
APC Medical, Ltd. (FEI: 3002806386) has 4 FDA import refusal record(s) in our database, spanning from 6/2/2010 to 10/30/2012.
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. APC Medical, Ltd.'s FEI number is 3002806386.
What types of violations has APC Medical, Ltd. received?
APC Medical, Ltd. 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 APC Medical, Ltd. come from?
All FDA import refusal data for APC Medical, Ltd. 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.