Affiliated Food Stores Inc.
⚠️ Moderate Risk
FEI: 3002766978 • Las Pinas City • PHILIPPINES
FEI Number
3002766978
Location
Las Pinas City
Country
PHILIPPINESAddress
Bf Resort Commercial Plaza, , Pamplona, Las Pinas City, , 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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/29/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | San Francisco District Office (SAN-DO) | |
| 6/9/2002 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 6/9/2002 | 62MBL08MENTHOL (ANTI-PRURITIC) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Affiliated Food Stores Inc.'s FDA import refusal history?
Affiliated Food Stores Inc. (FEI: 3002766978) has 3 FDA import refusal record(s) in our database, spanning from 6/9/2002 to 4/29/2004.
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. Affiliated Food Stores Inc.'s FEI number is 3002766978.
What types of violations has Affiliated Food Stores Inc. received?
Affiliated Food Stores Inc. has been cited for 4 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 Affiliated Food Stores Inc. come from?
All FDA import refusal data for Affiliated Food Stores Inc. 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.