SC PERLA HARGHITEI SA
⚠️ Moderate Risk
FEI: 3010178250 • Sancraieni, Harghita • ROMANIA
FEI Number
3010178250
Location
Sancraieni, Harghita
Country
ROMANIAAddress
Garii Street No 600, , Sancraieni, Harghita, Romania
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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
INCONSPICU
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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 |
|---|---|---|---|
| 9/19/2011 | 29BGT99CARBONATED SOFT DRINK, N.E.C. | Detroit District Office (DET-DO) | |
| 9/19/2011 | 29BGT99CARBONATED SOFT DRINK, N.E.C. | Detroit District Office (DET-DO) | |
| 9/14/2011 | 29BGT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 256INCONSPICU | Detroit District Office (DET-DO) |
| 9/14/2011 | 29BGT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 256INCONSPICU | Detroit District Office (DET-DO) |
| 9/21/2010 | 29BHT99CARBONATED SOFT DRINK, N.E.C. | 11UNSAFE COL | Detroit District Office (DET-DO) |
| 3/5/2010 | 29BGY99CARBONATED SOFT DRINK, N.E.C. | Detroit District Office (DET-DO) | |
| 4/24/2009 | 29BHY99CARBONATED SOFT DRINK, N.E.C. | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 4/24/2009 | 29BHY99CARBONATED SOFT DRINK, N.E.C. | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is SC PERLA HARGHITEI SA's FDA import refusal history?
SC PERLA HARGHITEI SA (FEI: 3010178250) has 8 FDA import refusal record(s) in our database, spanning from 4/24/2009 to 9/19/2011.
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. SC PERLA HARGHITEI SA's FEI number is 3010178250.
What types of violations has SC PERLA HARGHITEI SA received?
SC PERLA HARGHITEI SA has been cited for 4 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 SC PERLA HARGHITEI SA come from?
All FDA import refusal data for SC PERLA HARGHITEI SA 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.