Fabrica de Conservas la Gondola, Lda
⚠️ Moderate Risk
FEI: 3009678421 • Perafita, Porto • PORTUGAL
FEI Number
3009678421
Location
Perafita, Porto
Country
PORTUGALAddress
Rua Dom Marcos da Cruz, Lotes 19 /20, Perafita, Porto, Portugal
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
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.
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)).
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.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/8/2011 | 16AEE22MACKEREL (ONLY SCOMBEROMORUS SPP EG. SPANISH OR KING) | New York District Office (NYK-DO) | |
| 1/25/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | Detroit District Office (DET-DO) | |
| 8/10/2010 | 16AEE22MACKEREL (ONLY SCOMBEROMORUS SPP EG. SPANISH OR KING) | 83NO PROCESS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Fabrica de Conservas la Gondola, Lda's FDA import refusal history?
Fabrica de Conservas la Gondola, Lda (FEI: 3009678421) has 3 FDA import refusal record(s) in our database, spanning from 8/10/2010 to 2/8/2011.
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. Fabrica de Conservas la Gondola, Lda's FEI number is 3009678421.
What types of violations has Fabrica de Conservas la Gondola, Lda received?
Fabrica de Conservas la Gondola, Lda 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 Fabrica de Conservas la Gondola, Lda come from?
All FDA import refusal data for Fabrica de Conservas la Gondola, Lda 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.