G.A. Surgical (Pvt) Ltd.
⚠️ Moderate Risk
FEI: 3002807115 • Sialkot, Punjab • PAKISTAN
FEI Number
3002807115
Location
Sialkot, Punjab
Country
PAKISTANAddress
Kulluwal Road, Gohadpur, , Sialkot, Punjab, 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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/10/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 4/5/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 479DV QUALITY | New York District Office (NYK-DO) |
| 4/5/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 479DV QUALITY | New York District Office (NYK-DO) |
| 4/5/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 479DV QUALITY | New York District Office (NYK-DO) |
Frequently Asked Questions
What is G.A. Surgical (Pvt) Ltd.'s FDA import refusal history?
G.A. Surgical (Pvt) Ltd. (FEI: 3002807115) has 4 FDA import refusal record(s) in our database, spanning from 4/5/2010 to 8/10/2011.
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. G.A. Surgical (Pvt) Ltd.'s FEI number is 3002807115.
What types of violations has G.A. Surgical (Pvt) Ltd. received?
G.A. Surgical (Pvt) 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 G.A. Surgical (Pvt) Ltd. come from?
All FDA import refusal data for G.A. Surgical (Pvt) 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.