Allen Surgical Co.
⚠️ Moderate Risk
FEI: 1000462904 • Sialkot • PAKISTAN
FEI Number
1000462904
Location
Sialkot
Country
PAKISTANAddress
18-A-Small Industrial Estate, , 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
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).
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).
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/7/2018 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | Division of Northern Border Imports (DNBI) | |
| 10/19/2016 | 79GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY | Cincinnati District Office (CIN-DO) | |
| 10/19/2016 | 79FZSCURETTE, SURGICAL | Cincinnati District Office (CIN-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 6/11/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Florida District Office (FLA-DO) | |
| 5/21/2015 | 68XYY99OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL | Los Angeles District Office (LOS-DO) | |
| 5/10/2002 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Allen Surgical Co.'s FDA import refusal history?
Allen Surgical Co. (FEI: 1000462904) has 25 FDA import refusal record(s) in our database, spanning from 5/10/2002 to 5/7/2018.
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. Allen Surgical Co.'s FEI number is 1000462904.
What types of violations has Allen Surgical Co. received?
Allen Surgical Co. has been cited for 5 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 Allen Surgical Co. come from?
All FDA import refusal data for Allen 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.