BIGBRO
⚠️ Moderate Risk
FEI: 3006948502 • Sialkot, Punjab • PAKISTAN
FEI Number
3006948502
Location
Sialkot, Punjab
Country
PAKISTANAddress
Wazirabad Road, , 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
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).
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/8/2012 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Chicago District Office (CHI-DO) |
| 12/27/2011 | 80LDQDEVICE, GENERAL MEDICAL | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 12/27/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 12/27/2011 | 80LDQDEVICE, GENERAL MEDICAL | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 12/27/2011 | 80LDQDEVICE, GENERAL MEDICAL | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 12/27/2011 | 77KBDSCISSORS, NASAL | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 12/27/2011 | 80LDQDEVICE, GENERAL MEDICAL | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 5/27/2011 | 79HTDFORCEPS | Chicago District Office (CHI-DO) | |
| 5/27/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | Chicago District Office (CHI-DO) | |
| 2/18/2011 | 87HRRSCISSORS | Chicago District Office (CHI-DO) | |
| 8/11/2008 | 87HRRSCISSORS | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2008 | 79HTDFORCEPS | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/8/2004 | 76EMNSCALER, PERIODONTIC | New York District Office (NYK-DO) | |
| 11/8/2004 | 76EMNSCALER, PERIODONTIC | New York District Office (NYK-DO) |
Frequently Asked Questions
What is BIGBRO's FDA import refusal history?
BIGBRO (FEI: 3006948502) has 14 FDA import refusal record(s) in our database, spanning from 11/8/2004 to 2/8/2012.
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. BIGBRO's FEI number is 3006948502.
What types of violations has BIGBRO received?
BIGBRO 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 BIGBRO come from?
All FDA import refusal data for BIGBRO 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.