GOGI ENTERPRISES
✅ Low Risk
FEI: 1000627636 • Sialkot, Punjab • PAKISTAN
FEI Number
1000627636
Location
Sialkot, Punjab
Country
PAKISTANAddress
Defence Rd., Padana Gloves, P.O. Box 1367, Sialkot, Punjab, Pakistan
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/22/2010 | 76EMSCURETTE, PERIODONTIC | Los Angeles District Office (LOS-DO) | |
| 3/22/2010 | 76EMJELEVATOR, SURGICAL, DENTAL | Los Angeles District Office (LOS-DO) | |
| 3/22/2010 | 76EMHFORCEPS, RONGEUR, SURGICAL | Los Angeles District Office (LOS-DO) | |
| 1/3/2002 | 76EIGRETRACTOR, ALL TYPES | 118NOT LISTED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is GOGI ENTERPRISES's FDA import refusal history?
GOGI ENTERPRISES (FEI: 1000627636) has 4 FDA import refusal record(s) in our database, spanning from 1/3/2002 to 3/22/2010.
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. GOGI ENTERPRISES's FEI number is 1000627636.
What types of violations has GOGI ENTERPRISES received?
GOGI ENTERPRISES 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 GOGI ENTERPRISES come from?
All FDA import refusal data for GOGI ENTERPRISES 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.