PASCUAL LABORATORIES INCORPORATED
⚠️ Moderate Risk
FEI: 3004255594 • Balagtas, BULACAN • PHILIPPINES
FEI Number
3004255594
Location
Balagtas, BULACAN
Country
PHILIPPINESAddress
Km 31 Macarthur Highway, , Balagtas, BULACAN, 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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/8/2008 | 54FBE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/13/2006 | 62GCA48MEFENAMIC ACID (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/3/2005 | 56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is PASCUAL LABORATORIES INCORPORATED's FDA import refusal history?
PASCUAL LABORATORIES INCORPORATED (FEI: 3004255594) has 3 FDA import refusal record(s) in our database, spanning from 3/3/2005 to 4/8/2008.
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. PASCUAL LABORATORIES INCORPORATED's FEI number is 3004255594.
What types of violations has PASCUAL LABORATORIES INCORPORATED received?
PASCUAL LABORATORIES INCORPORATED 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 PASCUAL LABORATORIES INCORPORATED come from?
All FDA import refusal data for PASCUAL LABORATORIES INCORPORATED 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.