F & M Food Products
⚠️ Moderate Risk
FEI: 3004262632 • Laguna, Calabarzon • PHILIPPINES
FEI Number
3004262632
Location
Laguna, Calabarzon
Country
PHILIPPINESAddress
35 Maharlika Highway, San Juan, , Laguna, Calabarzon, 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.
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.
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 |
|---|---|---|---|
| 10/25/2013 | 25LCE12SWEET POTATO, DRIED OR PASTE | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 10/1/2013 | 25LCE12SWEET POTATO, DRIED OR PASTE | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 3/26/2007 | 24ACE10NAVY (WHITE) BEANS, (BAKED BEANS, PORK & BEANS) | 181UNDER PRC | Los Angeles District Office (LOS-DO) |
| 4/23/2004 | 62SBJ99ANTI-SEBORRHEIC N.E.C. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is F & M Food Products's FDA import refusal history?
F & M Food Products (FEI: 3004262632) has 4 FDA import refusal record(s) in our database, spanning from 4/23/2004 to 10/25/2013.
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. F & M Food Products's FEI number is 3004262632.
What types of violations has F & M Food Products received?
F & M Food Products 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 F & M Food Products come from?
All FDA import refusal data for F & M Food Products 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.