PHILPACK
⚠️ Moderate Risk
FEI: 3004280262 • Cagayan De Oro City, Misamis Oriental • PHILIPPINES
FEI Number
3004280262
Location
Cagayan De Oro City, Misamis Oriental
Country
PHILIPPINESAddress
15 km east of Cagayan de Oro, National Highway Bugo, Cagayan De Oro City, Misamis Oriental, 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
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.
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).
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).
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.
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.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/30/2013 | 21AYI01FRUIT COCKTAIL, MIXED FRUITS | San Francisco District Office (SAN-DO) | |
| 11/19/2013 | 21AYI01FRUIT COCKTAIL, MIXED FRUITS | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 6/29/2011 | 37JEI08TOMATO SAUCE (WITH OTHER INGREDIENTS) | San Francisco District Office (SAN-DO) | |
| 6/29/2011 | 37JEI08TOMATO SAUCE (WITH OTHER INGREDIENTS) | San Francisco District Office (SAN-DO) | |
| 1/31/2008 | 21AEE01FRUIT COCKTAIL, MIXED FRUITS | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 1/31/2008 | 21AEE01FRUIT COCKTAIL, MIXED FRUITS | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 5/26/2006 | 21AEI01FRUIT COCKTAIL, MIXED FRUITS | San Francisco District Office (SAN-DO) | |
| 5/26/2006 | 37BEI19SPAGHETTI (MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS) | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 1/19/2004 | 37JCT08TOMATO SAUCE (WITH OTHER INGREDIENTS) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/19/2004 | 37JCT08TOMATO SAUCE (WITH OTHER INGREDIENTS) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/26/2003 | 37JCE08TOMATO SAUCE (WITH OTHER INGREDIENTS) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/21/2002 | 21VET99SUTROPICAL AND TROPICAL FRUIT, JUICE, MILK, CREME, DRINK OR NECTAR, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is PHILPACK's FDA import refusal history?
PHILPACK (FEI: 3004280262) has 12 FDA import refusal record(s) in our database, spanning from 1/21/2002 to 12/30/2013.
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. PHILPACK's FEI number is 3004280262.
What types of violations has PHILPACK received?
PHILPACK 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 PHILPACK come from?
All FDA import refusal data for PHILPACK 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.