DR.MILTONS LABORATORIES PRIVATE LTD.
⚠️ Moderate Risk
FEI: 3009187251 • Pondicherry, Pondicherry • INDIA
FEI Number
3009187251
Location
Pondicherry, Pondicherry
Country
INDIAAddress
7/62 B, VILLIANUR ROAD,, , Pondicherry, Pondicherry, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/14/2017 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/29/2016 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/5/2016 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/1/2015 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/4/2013 | 66YAL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 10/26/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is DR.MILTONS LABORATORIES PRIVATE LTD.'s FDA import refusal history?
DR.MILTONS LABORATORIES PRIVATE LTD. (FEI: 3009187251) has 6 FDA import refusal record(s) in our database, spanning from 10/26/2011 to 3/14/2017.
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. DR.MILTONS LABORATORIES PRIVATE LTD.'s FEI number is 3009187251.
What types of violations has DR.MILTONS LABORATORIES PRIVATE LTD. received?
DR.MILTONS LABORATORIES PRIVATE LTD. has been cited for 2 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 DR.MILTONS LABORATORIES PRIVATE LTD. come from?
All FDA import refusal data for DR.MILTONS LABORATORIES PRIVATE LTD. 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.