Qarshi Industries (PVT) Ltd.
⚠️ Moderate Risk
FEI: 3004793236 • Hattar, PK-NW • PAKISTAN
FEI Number
3004793236
Location
Hattar, PK-NW
Country
PAKISTANAddress
56/2-3 Insustrial Estate, , Hattar, PK-NW, 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
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.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
PRESRV LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a chemical preservative and it fails to bear labeling stating that fact including its function.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/26/2018 | 31KGT02TEA, GREEN | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/10/2014 | 36BHT99SYRUPS AND MOLASSES, N.E.C. | New York District Office (NYK-DO) | |
| 7/10/2014 | 36BHT99SYRUPS AND MOLASSES, N.E.C. | New York District Office (NYK-DO) | |
| 7/24/2013 | 54EYY99HERBALS & BOTANICAL TEAS, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/5/2011 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/5/2011 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/5/2011 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/23/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/14/2009 | 54EEY99HERBALS & BOTANICAL TEAS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/26/2004 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 10/26/2004 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 10/26/2004 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Qarshi Industries (PVT) Ltd.'s FDA import refusal history?
Qarshi Industries (PVT) Ltd. (FEI: 3004793236) has 12 FDA import refusal record(s) in our database, spanning from 10/26/2004 to 3/26/2018.
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. Qarshi Industries (PVT) Ltd.'s FEI number is 3004793236.
What types of violations has Qarshi Industries (PVT) Ltd. received?
Qarshi Industries (PVT) Ltd. 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 Qarshi Industries (PVT) Ltd. come from?
All FDA import refusal data for Qarshi Industries (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.