International Pharmaceuticals, Inc.
⚠️ Moderate Risk
FEI: 3004679500 • Kasambagan, Cebu • PHILIPPINES
FEI Number
3004679500
Location
Kasambagan, Cebu
Country
PHILIPPINESAddress
Pope John Paul Ii Avenue, 3 Golam Drive, Kasambagan, Cebu, 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
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/29/2021 | 62MAL01CAMPHOR (ANTI-PRURITIC) | Division of Southeast Imports (DSEI) | |
| 7/3/2018 | 66VRE99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 4/26/2013 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/26/2013 | 62MBL01CAMPHOR (ANTI-PRURITIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/26/2013 | 62MBL01CAMPHOR (ANTI-PRURITIC) | Los Angeles District Office (LOS-DO) | |
| 2/5/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/5/2013 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/7/2012 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 12/7/2012 | 62HAL99ANTI-MICROBIAL N.E.C. | San Francisco District Office (SAN-DO) | |
| 10/14/2008 | 62QBL08SALICYLATE MEGLUMINE (ANTI-RHEUMATIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/1/2005 | 61XAA05CARBINOXAMINE MALEATE (ANTI-HISTAMINIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/3/2005 | 56YYY99ANTIBIOTIC N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 3/17/2004 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is International Pharmaceuticals, Inc.'s FDA import refusal history?
International Pharmaceuticals, Inc. (FEI: 3004679500) has 13 FDA import refusal record(s) in our database, spanning from 3/17/2004 to 10/29/2021.
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. International Pharmaceuticals, Inc.'s FEI number is 3004679500.
What types of violations has International Pharmaceuticals, Inc. received?
International Pharmaceuticals, Inc. 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 International Pharmaceuticals, Inc. come from?
All FDA import refusal data for International Pharmaceuticals, 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.