Holgard Trading Co
⚠️ Moderate Risk
FEI: 3004195755 • Sialkot • PAKISTAN
FEI Number
3004195755
Location
Sialkot
Country
PAKISTANAddress
Muhammadpura Commissioner Road, , 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
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).
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/28/2004 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | New York District Office (NYK-DO) |
| 4/28/2004 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 1/30/2004 | 24KCT07PEPPER, SWEET, WITH SAUCE | 62NEEDS FCE | New York District Office (NYK-DO) |
| 1/30/2004 | 21VEE05MANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT | 62NEEDS FCE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Holgard Trading Co's FDA import refusal history?
Holgard Trading Co (FEI: 3004195755) has 4 FDA import refusal record(s) in our database, spanning from 1/30/2004 to 4/28/2004.
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. Holgard Trading Co's FEI number is 3004195755.
What types of violations has Holgard Trading Co received?
Holgard Trading Co 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 Holgard Trading Co come from?
All FDA import refusal data for Holgard Trading Co 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.