G. Amphray Laboratories
⚠️ Moderate Risk
FEI: 3004257189 • Mumbai, Maharashtra • INDIA
FEI Number
3004257189
Location
Mumbai, Maharashtra
Country
INDIAAddress
Kamanwala Chambers, 4th Floor; Sir P M Road; Fort, Mumbai, Maharashtra, India
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
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.
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/24/2016 | 60WOS27PIPERAZINE CITRATE (ANTHELMINTIC) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 1/28/2016 | 60WCZ27PIPERAZINE CITRATE (ANTHELMINTIC) | 72NEW VET DR | Division of West Coast Imports (DWCI) |
| 12/16/2011 | 56GAS99ANTIFUNGAL N.E.C. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 12/10/2010 | 61ACS08DIIODOHYDROXYQUIN (ANTI-AMEBIC) | Los Angeles District Office (LOS-DO) | |
| 9/27/2010 | 67B74PIPERAZINE CATEGORY II, TYPE A MEDICATED ARTICLE | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 2/20/2004 | 63XAY99DIAGOSTIC AID (DRUGS) N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 12/20/2001 | 62GAS41IBUPROFEN (ANTI-INFLAMMATORY) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is G. Amphray Laboratories's FDA import refusal history?
G. Amphray Laboratories (FEI: 3004257189) has 7 FDA import refusal record(s) in our database, spanning from 12/20/2001 to 5/24/2016.
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. G. Amphray Laboratories's FEI number is 3004257189.
What types of violations has G. Amphray Laboratories received?
G. Amphray Laboratories 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 G. Amphray Laboratories come from?
All FDA import refusal data for G. Amphray 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.