Pleasant Surgico
⚠️ Moderate Risk
FEI: 3001340284 • Sialkot • PAKISTAN
FEI Number
3001340284
Location
Sialkot
Country
PAKISTANAddress
P.O. Box 1518, Muhammad Pura, 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).
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/15/2015 | 68XYY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 8/7/2014 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | 16DIRECTIONS | Detroit District Office (DET-DO) |
| 9/18/2013 | 77JYASCISSORS, WIRE CUTTING, ENT | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 79GESBLADE, SCALPEL | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 77JYASCISSORS, WIRE CUTTING, ENT | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 76ECNCLAMP, WIRE, ORTHODONTIC | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 76ECNCLAMP, WIRE, ORTHODONTIC | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 76ECNCLAMP, WIRE, ORTHODONTIC | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 76ECNCLAMP, WIRE, ORTHODONTIC | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 76ECNCLAMP, WIRE, ORTHODONTIC | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 79HTDFORCEPS | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 79HTDFORCEPS | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 76EKBEXPLORER, OPERATIVE | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 79FTYTAPE, MEASURING, RULERS AND CALIPERS | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 76DZNMATRIX, DENTAL | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 76DZNMATRIX, DENTAL | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 79FTYTAPE, MEASURING, RULERS AND CALIPERS | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 76EMNSCALER, PERIODONTIC | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 76EKCEXCAVATOR, DENTAL, OPERATIVE | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 76EKCEXCAVATOR, DENTAL, OPERATIVE | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 76EISREMOVER, CROWN | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 79HTDFORCEPS | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 79HTDFORCEPS | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 76DZNMATRIX, DENTAL | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 79HTDFORCEPS | 118NOT LISTED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Pleasant Surgico's FDA import refusal history?
Pleasant Surgico (FEI: 3001340284) has 26 FDA import refusal record(s) in our database, spanning from 9/18/2013 to 7/15/2015.
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. Pleasant Surgico's FEI number is 3001340284.
What types of violations has Pleasant Surgico received?
Pleasant Surgico 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 Pleasant Surgico come from?
All FDA import refusal data for Pleasant Surgico 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.