Joe Familar
⚠️ Moderate Risk
FEI: 3005036416 • Zamboanga City • PHILIPPINES
FEI Number
3005036416
Location
Zamboanga City
Country
PHILIPPINESAddress
Veterans Ave, , Zamboanga 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).
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.
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 |
|---|---|---|---|
| 5/3/2005 | 66SCA48ISOSORBIDE MONONITRATE (VASODILATOR) | San Francisco District Office (SAN-DO) | |
| 5/3/2005 | 62OCA37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | San Francisco District Office (SAN-DO) | |
| 5/3/2005 | 62OCA44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | San Francisco District Office (SAN-DO) | |
| 5/3/2005 | 60LAA05ASPIRIN (ANALGESIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Joe Familar's FDA import refusal history?
Joe Familar (FEI: 3005036416) has 4 FDA import refusal record(s) in our database, spanning from 5/3/2005 to 5/3/2005.
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. Joe Familar's FEI number is 3005036416.
What types of violations has Joe Familar received?
Joe Familar 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 Joe Familar come from?
All FDA import refusal data for Joe Familar 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.