Au Natural Stones
⚠️ Moderate Risk
FEI: 3005126598 • Karachi, SIND • PAKISTAN
FEI Number
3005126598
Location
Karachi, SIND
Country
PAKISTANAddress
111/3 Khayben-E-Ittehand, Phase 6 Dha, Karachi, SIND, 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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/8/2019 | 77KCOINHALER, NASAL | 223FALSE | Division of Northern Border Imports (DNBI) |
| 4/2/2013 | 77KCOINHALER, NASAL | Detroit District Office (DET-DO) | |
| 1/16/2013 | 77KCOINHALER, NASAL | Cincinnati District Office (CIN-DO) | |
| 1/16/2013 | 65RAR99REPLENISHER N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 12/14/2012 | 77KCOINHALER, NASAL | 2380NO PMA/PDP | New York District Office (NYK-DO) |
| 10/19/2012 | 53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/13/2012 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New York District Office (NYK-DO) | |
| 9/13/2012 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New York District Office (NYK-DO) | |
| 6/19/2012 | 77KCOINHALER, NASAL | Seattle District Office (SEA-DO) | |
| 12/2/2011 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 12/2/2011 | 77KCOINHALER, NASAL | Detroit District Office (DET-DO) | |
| 12/2/2011 | 77KCOINHALER, NASAL | 118NOT LISTED | Detroit District Office (DET-DO) |
| 11/29/2011 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 6/2/2011 | 77KCOINHALER, NASAL | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/2/2011 | 77KCOINHALER, NASAL | New York District Office (NYK-DO) | |
| 4/4/2011 | 54BDY12SODIUM (MINERAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/9/2010 | 77KCOINHALER, NASAL | New York District Office (NYK-DO) | |
| 8/20/2010 | 77KCOINHALER, NASAL | New York District Office (NYK-DO) | |
| 8/20/2010 | 77KCOINHALER, NASAL | New York District Office (NYK-DO) | |
| 8/20/2010 | 77KCOINHALER, NASAL | New York District Office (NYK-DO) | |
| 8/18/2010 | 77KCOINHALER, NASAL | New York District Office (NYK-DO) | |
| 7/21/2010 | 77KCOINHALER, NASAL | New York District Office (NYK-DO) | |
| 6/22/2010 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 6/22/2010 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Au Natural Stones's FDA import refusal history?
Au Natural Stones (FEI: 3005126598) has 24 FDA import refusal record(s) in our database, spanning from 6/22/2010 to 4/8/2019.
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. Au Natural Stones's FEI number is 3005126598.
What types of violations has Au Natural Stones received?
Au Natural Stones has been cited for 11 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 Au Natural Stones come from?
All FDA import refusal data for Au Natural Stones 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.