Spiral Surgical Co
⚠️ Moderate Risk
FEI: 3009417877 • Sialkot • PAKISTAN
FEI Number
3009417877
Location
Sialkot
Country
PAKISTANAddress
West Murad Pur, , Sialkot, , Pakistan
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
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/1/2022 | 68ZYG99ANIMAL MEDICAL DEVICES, NEC | Division of Southeast Imports (DSEI) | |
| 2/3/2014 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 2/3/2014 | 79GFJMALLET, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 2/3/2014 | 79GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Spiral Surgical Co's FDA import refusal history?
Spiral Surgical Co (FEI: 3009417877) has 4 FDA import refusal record(s) in our database, spanning from 2/3/2014 to 2/1/2022.
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. Spiral Surgical Co's FEI number is 3009417877.
What types of violations has Spiral Surgical Co received?
Spiral Surgical Co has been cited for 3 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 Spiral Surgical Co come from?
All FDA import refusal data for Spiral Surgical 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.