Rkz Surgical (Pvt), Ltd.
⚠️ Moderate Risk
FEI: 3002808010 • Sialkot • PAKISTAN
FEI Number
3002808010
Location
Sialkot
Country
PAKISTANAddress
Kulluwal Rd., Gohadpur, , 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
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.
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 |
|---|---|---|---|
| 2/28/2013 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 2/28/2013 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/19/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Rkz Surgical (Pvt), Ltd.'s FDA import refusal history?
Rkz Surgical (Pvt), Ltd. (FEI: 3002808010) has 3 FDA import refusal record(s) in our database, spanning from 8/19/2011 to 2/28/2013.
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. Rkz Surgical (Pvt), Ltd.'s FEI number is 3002808010.
What types of violations has Rkz Surgical (Pvt), Ltd. received?
Rkz 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 Rkz Surgical (Pvt), Ltd. come from?
All FDA import refusal data for Rkz 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.