Interphil Lab Inc
⚠️ Moderate Risk
FEI: 3002945792 • Laguna • PHILIPPINES
FEI Number
3002945792
Location
Laguna
Country
PHILIPPINESAddress
Canlubang Industrial Estate, , Laguna, , 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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/6/2011 | 56BCH03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | San Francisco District Office (SAN-DO) | |
| 8/23/2010 | 62OCA39LABETALOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 6/3/2010 | 62UCK99ANTI-TUSSIVE/COLD N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/23/2009 | 64UDB02ACARBOSE (INHIBITOR (DECARBOXYLASE)) | San Francisco District Office (SAN-DO) | |
| 8/26/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 1/10/2008 | 64LCA56PREDNISONE (GLUCOCORTICOID) | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 11/23/2007 | 64XCJ07TRETINOIN (KERATOLYTIC) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 9/25/2007 | 56DYO41NEOMYCIN SULFATE (AMINOGLYCOSIDES) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/1/2006 | 60CAY02DOPAMINE HCL (ADRENERGIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 3/27/2006 | 56EDY80TETRACYCLINE (TETRACYCLINES) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/27/2005 | 62FCJ29NITROFURAZONE (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/27/2005 | 61PCB26METFORMIN (ANTI-DIABETIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/22/2005 | 56BCB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/22/2005 | 63XAY99DIAGOSTIC AID (DRUGS) N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/14/2005 | 61ECQ99ANTI-ASTHMATIC, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/1/2005 | 64UCC02ACARBOSE (INHIBITOR (DECARBOXYLASE)) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 5/24/2005 | 64LCA56PREDNISONE (GLUCOCORTICOID) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 5/20/2005 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 5/16/2005 | 56YDB99ANTIBIOTIC N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/10/2004 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 9/10/2002 | 63XAY99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Interphil Lab Inc's FDA import refusal history?
Interphil Lab Inc (FEI: 3002945792) has 21 FDA import refusal record(s) in our database, spanning from 9/10/2002 to 7/6/2011.
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. Interphil Lab Inc's FEI number is 3002945792.
What types of violations has Interphil Lab Inc received?
Interphil Lab Inc 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 Interphil Lab Inc come from?
All FDA import refusal data for Interphil Lab 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.