Ultra Surgical (Pvt.) Ltd.
⚠️ Moderate Risk
FEI: 3000321209 • Sialkot, Punjab • PAKISTAN
FEI Number
3000321209
Location
Sialkot, Punjab
Country
PAKISTANAddress
Roras 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
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.
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).
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 |
|---|---|---|---|
| 10/18/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | Southwest Import District Office (SWI-DO) | |
| 10/18/2011 | 76EFLFORCEPS, DRESSING, DENTAL | Southwest Import District Office (SWI-DO) | |
| 10/18/2011 | 78FHQHOLDER, NEEDLE | Southwest Import District Office (SWI-DO) | |
| 10/18/2011 | 76EFLFORCEPS, DRESSING, DENTAL | Southwest Import District Office (SWI-DO) | |
| 10/18/2011 | 76EMDHEMOSTAT, SURGICAL | Southwest Import District Office (SWI-DO) | |
| 10/18/2011 | 79KDDKIT, SURGICAL INSTRUMENT, DISPOSABLE | Southwest Import District Office (SWI-DO) | |
| 7/6/2011 | 79KDDKIT, SURGICAL INSTRUMENT, DISPOSABLE | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 12/13/2010 | 79FSMTRAY, SURGICAL, INSTRUMENT | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Ultra Surgical (Pvt.) Ltd.'s FDA import refusal history?
Ultra Surgical (Pvt.) Ltd. (FEI: 3000321209) has 8 FDA import refusal record(s) in our database, spanning from 12/13/2010 to 10/18/2011.
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. Ultra Surgical (Pvt.) Ltd.'s FEI number is 3000321209.
What types of violations has Ultra Surgical (Pvt.) Ltd. received?
Ultra Surgical (Pvt.) Ltd. has been cited for 3 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 Ultra Surgical (Pvt.) Ltd. come from?
All FDA import refusal data for Ultra 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.