Bethany Sales
⚠️ High Risk
FEI: 3003667815 • Mandaluyong • PHILIPPINES
FEI Number
3003667815
Location
Mandaluyong
Country
PHILIPPINESAddress
903 Paragon Plaza, , Mandaluyong, , Philippines
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
UNDER PRC
The article appears to have inadequate processing in having been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
AFLATOXIN
The article appears to contain a mycotoxin, a poisonous and deleterious substance which may render it injurious to health.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
NEEDS ACID
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health due to inadequate acidification.
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/1/2022 | 37JCT02BARBECUE SAUCE | 249FILTHY | Division of West Coast Imports (DWCI) |
| 7/25/2018 | 37JGT13BANANA SAUCE | 62NEEDS FCE | Division of Southeast Imports (DSEI) |
| 7/25/2018 | 37JYY05SOY SAUCE | 48NEEDS ACID | Division of Southeast Imports (DSEI) |
| 5/24/2013 | 16AGP99FISH, N.E.C. | 308MFR INSAN | San Francisco District Office (SAN-DO) |
| 9/1/2005 | 03HEE99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C. | 181UNDER PRC | San Francisco District Office (SAN-DO) |
| 1/28/2005 | 30JGT04BEVERAGE BASE, IMITATION MIXED FRUIT | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 1/28/2005 | 07BGT99FRIED SNACK FOODS, N.E.C. | 11UNSAFE COL | Division of West Coast Imports (DWCI) |
| 6/7/2004 | 66VBU99MISCELLANEOUS PATENT MEDICINES, ETC. | 223FALSE | Los Angeles District Office (LOS-DO) |
| 6/7/2004 | 53JA01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/8/2004 | 34CHT02CHOCOLATE CANDY PIECES, WITH NUTS OR NUT PRODUCTS (NOT COCONUT) | 297AFLATOXIN | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Bethany Sales's FDA import refusal history?
Bethany Sales (FEI: 3003667815) has 10 FDA import refusal record(s) in our database, spanning from 1/8/2004 to 9/1/2022.
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. Bethany Sales's FEI number is 3003667815.
What types of violations has Bethany Sales received?
Bethany Sales has been cited for 9 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 Bethany Sales come from?
All FDA import refusal data for Bethany Sales 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.