TETRA PAK PROCESSING SYSTEMS A/S
⚠️ Moderate Risk
FEI: 3013483882 • Hojbjerg • DENMARK
FEI Number
3013483882
Location
Hojbjerg
Country
DENMARKAddress
Soren Nymarks Vej 13, , Hojbjerg, , Denmark
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
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
VETDRUGRES
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains
NUTRIT LBL
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 fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/18/2014 | 16AVD15EEL | 2860VETDRUGRES | San Francisco District Office (SAN-DO) |
| 7/18/2012 | 16AGT59SCAD | 9SALMONELLA | Baltimore District Office (BLT-DO) |
| 7/18/2012 | 16AGT59SCAD | 9SALMONELLA | Baltimore District Office (BLT-DO) |
| 7/18/2012 | 16AGT59SCAD | 9SALMONELLA | Baltimore District Office (BLT-DO) |
| 1/9/2012 | 16AGT73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') | 308MFR INSAN | Baltimore District Office (BLT-DO) |
| 1/9/2012 | 16AGT73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') | 308MFR INSAN | Baltimore District Office (BLT-DO) |
| 7/29/2011 | 16MGD14SNAILS, AQUATIC, OTHER AQUATIC SPECIES | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 5/12/2011 | 16MGD14SNAILS, AQUATIC, OTHER AQUATIC SPECIES | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is TETRA PAK PROCESSING SYSTEMS A/S's FDA import refusal history?
TETRA PAK PROCESSING SYSTEMS A/S (FEI: 3013483882) has 8 FDA import refusal record(s) in our database, spanning from 5/12/2011 to 8/18/2014.
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. TETRA PAK PROCESSING SYSTEMS A/S's FEI number is 3013483882.
What types of violations has TETRA PAK PROCESSING SYSTEMS A/S received?
TETRA PAK PROCESSING SYSTEMS A/S has been cited for 5 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 TETRA PAK PROCESSING SYSTEMS A/S come from?
All FDA import refusal data for TETRA PAK PROCESSING SYSTEMS A/S 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.