M.A. Pak Surgico
⚠️ High Risk
FEI: 3002558296 • Sialkot • PAKISTAN
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
STAINSTEEL
The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.
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).
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 |
|---|---|---|---|
| 5/1/2008 | 76EIGRETRACTOR, ALL TYPES | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/22/2006 | 77KBNGAG, MOUTH | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/3/2006 | 76EIXPROBE, PERIODONTIC | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/3/2006 | 76EKECURETTE, OPERATIVE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/3/2006 | 76EIGRETRACTOR, ALL TYPES | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/3/2006 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/3/2006 | 77KAKPROBE, ENT | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2006 | 76EIGRETRACTOR, ALL TYPES | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/7/2005 | 76EKECURETTE, OPERATIVE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/7/2005 | 76EIXPROBE, PERIODONTIC | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/7/2005 | 76EMSCURETTE, PERIODONTIC | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/7/2005 | 76EIGRETRACTOR, ALL TYPES | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/7/2005 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/7/2005 | 76EMJELEVATOR, SURGICAL, DENTAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/7/2005 | 79KAMCANNULA, SINUS | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/7/2005 | 79HTFCURETTE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 2/11/2005 | 76EIGRETRACTOR, ALL TYPES | 290DE IMP GMP | New York District Office (NYK-DO) |
| 1/27/2005 | 76EMJELEVATOR, SURGICAL, DENTAL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is M.A. Pak Surgico's FDA import refusal history?
M.A. Pak Surgico (FEI: 3002558296) has 18 FDA import refusal record(s) in our database, spanning from 1/27/2005 to 5/1/2008.
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. M.A. Pak Surgico's FEI number is 3002558296.
What types of violations has M.A. Pak Surgico received?
M.A. Pak Surgico has been cited for 4 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 M.A. Pak Surgico come from?
All FDA import refusal data for M.A. Pak 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.