G.D. Pharmaceuticals Private Limited
⚠️ High Risk
FEI: 3008701714 • Ghaziabad, Uttar Pradesh • INDIA
FEI Number
3008701714
Location
Ghaziabad, Uttar Pradesh
Country
INDIAAddress
R N I Colony, 41/42 43 Mohun Nagar; S B I Colony 1'St Road, Ghaziabad, Uttar Pradesh, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/30/2025 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/15/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 11/6/2013 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/6/2013 | 66YBR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/21/2012 | 62FBJ99ANTI-INFECTIVE, TOPICAL N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/7/2011 | 66YDJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is G.D. Pharmaceuticals Private Limited's FDA import refusal history?
G.D. Pharmaceuticals Private Limited (FEI: 3008701714) has 6 FDA import refusal record(s) in our database, spanning from 10/7/2011 to 1/30/2025.
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.D. Pharmaceuticals Private Limited's FEI number is 3008701714.
What types of violations has G.D. Pharmaceuticals Private Limited received?
G.D. Pharmaceuticals Private Limited 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.D. Pharmaceuticals Private Limited come from?
All FDA import refusal data for G.D. Pharmaceuticals Private Limited 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.