Laboratoires Quinton International S.L.
⚠️ Moderate Risk
FEI: 3004792693 • Cox, Alicante • SPAIN
FEI Number
3004792693
Location
Cox, Alicante
Country
SPAINAddress
C Aznar, 6 - P.I Virgen del Carmen, , Cox, Alicante, Spain
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
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 |
|---|---|---|---|
| 7/6/2012 | 41YCT99DIETARY CONVENTIONAL FOODS, N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 6/25/2012 | 64WAY99IRRIGATION SOLUTION N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 6/25/2012 | 41YCT99DIETARY CONVENTIONAL FOODS, N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 5/25/2006 | 54ACL99VITAMIN, N.E.C. | New Orleans District Office (NOL-DO) | |
| 8/3/2005 | 65BBL99MUCOLYTIC N.E.C. | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 8/3/2005 | 65BBL99MUCOLYTIC N.E.C. | 118NOT LISTED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Laboratoires Quinton International S.L.'s FDA import refusal history?
Laboratoires Quinton International S.L. (FEI: 3004792693) has 6 FDA import refusal record(s) in our database, spanning from 8/3/2005 to 7/6/2012.
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. Laboratoires Quinton International S.L.'s FEI number is 3004792693.
What types of violations has Laboratoires Quinton International S.L. received?
Laboratoires Quinton International S.L. 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 Laboratoires Quinton International S.L. come from?
All FDA import refusal data for Laboratoires Quinton International S.L. 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.