Przedsiebiorstwo Produkcyjne Helena
⚠️ High Risk
FEI: 3002700053 • Kalisz • POLAND
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
CYCLAMATE
The article appears to bear or contain cyclamate, an unsafe food additive within the meaning of Section 409
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).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/30/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 2640CYCLAMATE | New York District Office (NYK-DO) |
| 7/30/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 2640CYCLAMATE | New York District Office (NYK-DO) |
| 7/30/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 2640CYCLAMATE | New York District Office (NYK-DO) |
| 7/30/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 2640CYCLAMATE | New York District Office (NYK-DO) |
| 7/30/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 2640CYCLAMATE | New York District Office (NYK-DO) |
| 7/30/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 2640CYCLAMATE | New York District Office (NYK-DO) |
| 7/30/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 2640CYCLAMATE | New York District Office (NYK-DO) |
| 7/30/2003 | 29ACT99NONCARBONATED SOFT DRINK, N.E.C. | 238UNSAFE ADD | New York District Office (NYK-DO) |
| 5/12/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 276PRESRV LBL | New York District Office (NYK-DO) |
| 5/12/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 276PRESRV LBL | New York District Office (NYK-DO) |
| 5/12/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 276PRESRV LBL | New York District Office (NYK-DO) |
| 5/12/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 276PRESRV LBL | New York District Office (NYK-DO) |
| 5/12/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 276PRESRV LBL | New York District Office (NYK-DO) |
| 5/12/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 276PRESRV LBL | New York District Office (NYK-DO) |
| 5/12/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 276PRESRV LBL | New York District Office (NYK-DO) |
| 5/12/2003 | 29AGE99NONCARBONATED SOFT DRINK, N.E.C. | 276PRESRV LBL | New York District Office (NYK-DO) |
| 1/13/2003 | 24JDE99FRUITS USED AS VEGETABLES, JUICE, N.E.C. | Chicago District Office (CHI-DO) | |
| 12/3/2002 | 21VDE02BANANA, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Przedsiebiorstwo Produkcyjne Helena's FDA import refusal history?
Przedsiebiorstwo Produkcyjne Helena (FEI: 3002700053) has 18 FDA import refusal record(s) in our database, spanning from 12/3/2002 to 7/30/2003.
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. Przedsiebiorstwo Produkcyjne Helena's FEI number is 3002700053.
What types of violations has Przedsiebiorstwo Produkcyjne Helena received?
Przedsiebiorstwo Produkcyjne Helena 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 Przedsiebiorstwo Produkcyjne Helena come from?
All FDA import refusal data for Przedsiebiorstwo Produkcyjne Helena 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.