United Laboratories Inc
⚠️ Moderate Risk
FEI: 3003621956 • Metro Manila, National Capital Region • PHILIPPINES
FEI Number
3003621956
Location
Metro Manila, National Capital Region
Country
PHILIPPINESAddress
66 United St Industrial Site, , Metro Manila, National Capital Region, 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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/10/2015 | 53BD99OTHER BATH PREPARATIONS, N.E.C. | Chicago District Office (CHI-DO) | |
| 4/9/2010 | 60CCA09PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 8/12/2009 | 60LCE83CELECOXIB (ANALGESIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/3/2008 | 60LCB99ANALGESIC, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/23/2008 | 62ODC41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 1/10/2008 | 65BCH03CARBOCYSTEINE (MUCOLYTIC) | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 12/11/2007 | 64BCB40TRIAMTERENE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/11/2007 | 60XCB17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/20/2007 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 9/26/2007 | 66KDY99THYROID INHIBITOR N.E.C. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 8/28/2007 | 61JDB14SIMVASTATIN (ANTI-CHOLESTEREMIC) | San Francisco District Office (SAN-DO) | |
| 3/15/2007 | 61XDB99ANTI-HISTAMINIC N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/23/2007 | 62YLA07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 1/23/2007 | 66TLA01ALLOPURINOL (XANTHINE OXIDASE INHIBITOR) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 11/8/2006 | 64BRY99DIURETIC N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 9/13/2006 | 62GCB48MEFENAMIC ACID (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2005 | 60LAB05ASPIRIN (ANALGESIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/5/2005 | 64UCB99INHIBITOR N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/29/2005 | 56BAA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/18/2005 | 61PDB55METFORMIN HCL (ANTI-DIABETIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/14/2005 | 61ECQ99ANTI-ASTHMATIC, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/8/2005 | 61ECA99ANTI-ASTHMATIC, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/8/2005 | 61ECA99ANTI-ASTHMATIC, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/18/2005 | 65BDL03CARBOCYSTEINE (MUCOLYTIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/12/2005 | 62GDY48MEFENAMIC ACID (ANTI-INFLAMMATORY) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/12/2005 | 56YDY99ANTIBIOTIC N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 9/2/2005 | 63XDY99DIAGOSTIC AID (DRUGS) N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/11/2005 | 56BDY05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/11/2005 | 61KDY99ANTI-CHOLINERGIC, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/11/2005 | 56KDY10CHLORAMPHENICOL | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 7/20/2005 | 60XDB17ATENOLOL (ANTI-ADRENERGIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 7/9/2005 | 62GBB48MEFENAMIC ACID (ANTI-INFLAMMATORY) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 5/16/2005 | 56YDB99ANTIBIOTIC N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 5/16/2005 | 56YDB99ANTIBIOTIC N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/16/2004 | 60XCY17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is United Laboratories Inc's FDA import refusal history?
United Laboratories Inc (FEI: 3003621956) has 35 FDA import refusal record(s) in our database, spanning from 1/16/2004 to 4/10/2015.
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. United Laboratories Inc's FEI number is 3003621956.
What types of violations has United Laboratories Inc received?
United Laboratories Inc has been cited for 5 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 United Laboratories Inc come from?
All FDA import refusal data for United Laboratories 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.