Z.F. Muaaz & Co.
⚠️ Moderate Risk
FEI: 3003568021 • Sialkot • PAKISTAN
FEI Number
3003568021
Location
Sialkot
Country
PAKISTANAddress
Mughal St., Jinnah Town, Defence Rd., 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
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 |
|---|---|---|---|
| 8/12/2002 | 76EIFACCESSORIES, RETRACTOR, DENTAL | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/12/2002 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/12/2002 | 79GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/12/2002 | 76EMJELEVATOR, SURGICAL, DENTAL | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Z.F. Muaaz & Co.'s FDA import refusal history?
Z.F. Muaaz & Co. (FEI: 3003568021) has 4 FDA import refusal record(s) in our database, spanning from 8/12/2002 to 8/12/2002.
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. Z.F. Muaaz & Co.'s FEI number is 3003568021.
What types of violations has Z.F. Muaaz & Co. received?
Z.F. Muaaz & Co. 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 Z.F. Muaaz & Co. come from?
All FDA import refusal data for Z.F. Muaaz & Co. 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.