Dolphin Enterprises
⚠️ Moderate Risk
FEI: 3011400994 • Sialkot, Punjab • PAKISTAN
FEI Number
3011400994
Location
Sialkot, Punjab
Country
PAKISTANAddress
Talwara Mughlan Jammu 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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 |
|---|---|---|---|
| 1/12/2016 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | New Orleans District Office (NOL-DO) | |
| 9/25/2015 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | Cincinnati District Office (CIN-DO) | |
| 9/14/2015 | 79OZCOVER THE COUNTER ACNE TREATMENT | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Dolphin Enterprises's FDA import refusal history?
Dolphin Enterprises (FEI: 3011400994) has 3 FDA import refusal record(s) in our database, spanning from 9/14/2015 to 1/12/2016.
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. Dolphin Enterprises's FEI number is 3011400994.
What types of violations has Dolphin Enterprises received?
Dolphin Enterprises has been cited for 6 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 Dolphin Enterprises come from?
All FDA import refusal data for Dolphin 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.