UNIVERSAL ROBINA CORPORATION
⚠️ Moderate Risk
FEI: 3010145693 • Quezon, National Capital Region (Manil • PHILIPPINES
FEI Number
3010145693
Location
Quezon, National Capital Region (Manil
Country
PHILIPPINESAddress
110 E. Rodriguez Jr. Avenue Libis, , Quezon, National Capital Region (Manil, 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).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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 |
|---|---|---|---|
| 1/3/2011 | 07BGT06POTATO CHIPS,FRIED | 274COLOR LBLG | Los Angeles District Office (LOS-DO) |
| 11/20/2003 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/20/2003 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/20/2003 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/20/2003 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is UNIVERSAL ROBINA CORPORATION's FDA import refusal history?
UNIVERSAL ROBINA CORPORATION (FEI: 3010145693) has 5 FDA import refusal record(s) in our database, spanning from 11/20/2003 to 1/3/2011.
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. UNIVERSAL ROBINA CORPORATION's FEI number is 3010145693.
What types of violations has UNIVERSAL ROBINA CORPORATION received?
UNIVERSAL ROBINA CORPORATION has been cited for 3 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 UNIVERSAL ROBINA CORPORATION come from?
All FDA import refusal data for UNIVERSAL ROBINA CORPORATION 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.