Probiotics International Limited
⚠️ Moderate Risk
FEI: 3003940391 • Somerset • UNITED KINGDOM
FEI Number
3003940391
Location
Somerset
Country
UNITED KINGDOMAddress
Matts Lane Stoke Sub Hamdon, , Somerset, , United Kingdom
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
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 4/26/2016 | 54AEB90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 3300ALLERGEN | New Orleans District Office (NOL-DO) |
| 3/16/2016 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 473LABELING | Cincinnati District Office (CIN-DO) |
| 12/14/2015 | 54AYY99VITAMIN, N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Probiotics International Limited's FDA import refusal history?
Probiotics International Limited (FEI: 3003940391) has 3 FDA import refusal record(s) in our database, spanning from 12/14/2015 to 4/26/2016.
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. Probiotics International Limited's FEI number is 3003940391.
What types of violations has Probiotics International Limited received?
Probiotics International Limited 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 Probiotics International Limited come from?
All FDA import refusal data for Probiotics International Limited 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.