AIRAH BOBADILLA
⚠️ Moderate Risk
FEI: 3013211984 • Gen Trias Cavit • PHILIPPINES
FEI Number
3013211984
Location
Gen Trias Cavit
Country
PHILIPPINESAddress
B62 L18 Villaggio, , Gen Trias Cavit, , Philippines
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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
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.
LACKS N/C
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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
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 |
|---|---|---|---|
| 4/26/2017 | 34BGT09MILK CHOCOLATE, SWEET MILK CHOCOLATE AND COATING (EXCEPT CHOCOLATE CANDY AND CHOCOLATE BEVERAGE BASE | Division of Southeast Imports (DSEI) | |
| 4/26/2017 | 31AGT03COFFEE, INSTANT | Division of Southeast Imports (DSEI) | |
| 4/26/2017 | 80ORCAIR FILTER PORTABLE APPARATUS | Division of Southeast Imports (DSEI) | |
| 4/26/2017 | 80ORCAIR FILTER PORTABLE APPARATUS | Division of Southeast Imports (DSEI) | |
| 4/26/2017 | 89OMWADHESIVE BACKED THERMAL SKIN PATCHES | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is AIRAH BOBADILLA's FDA import refusal history?
AIRAH BOBADILLA (FEI: 3013211984) has 5 FDA import refusal record(s) in our database, spanning from 4/26/2017 to 4/26/2017.
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. AIRAH BOBADILLA's FEI number is 3013211984.
What types of violations has AIRAH BOBADILLA received?
AIRAH BOBADILLA 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 AIRAH BOBADILLA come from?
All FDA import refusal data for AIRAH BOBADILLA 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.