Amherst Laboratories
⚠️ Moderate Risk
FEI: 3006576762 • Laguna, Calabarzon • PHILIPPINES
FEI Number
3006576762
Location
Laguna, Calabarzon
Country
PHILIPPINESAddress
Greenfield Industrial, , Laguna, Calabarzon, 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).
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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.
LACKS N/C
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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
DIETARYING
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or , with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/19/2024 | 54ACL99VITAMIN, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/6/2023 | 54AGT99VITAMIN, N.E.C. | Division of West Coast Imports (DWCI) | |
| 8/12/2013 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/29/2012 | 61JDB09FENOFIBRATE (ANTI-CHOLESTEREMIC) | San Francisco District Office (SAN-DO) | |
| 3/2/2011 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 3/2/2011 | 61JCA14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 1/5/2011 | 56ICB10ERYTHROMYCIN (MACROLIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/3/2008 | 60LCB05ASPIRIN (ANALGESIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/3/2008 | 62ODB41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/3/2008 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Amherst Laboratories's FDA import refusal history?
Amherst Laboratories (FEI: 3006576762) has 10 FDA import refusal record(s) in our database, spanning from 12/3/2008 to 12/19/2024.
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. Amherst Laboratories's FEI number is 3006576762.
What types of violations has Amherst Laboratories received?
Amherst Laboratories has been cited for 8 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 Amherst Laboratories come from?
All FDA import refusal data for Amherst Laboratories 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.