Promed Laboratories
⚠️ Moderate Risk
FEI: 3010380229 • Indore, Madhya Pradesh • INDIA
FEI Number
3010380229
Location
Indore, Madhya Pradesh
Country
INDIAAddress
35 - A/4 Laxminagar, , Indore, Madhya Pradesh, 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).
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/4/2019 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 9/7/2018 | 60SAL99ANTACID, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/15/2016 | 60SAL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/3/2016 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/19/2016 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/5/2015 | 60SBL99ANTACID, N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/2/2014 | 54FCK99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 5/8/2014 | 60SBL99ANTACID, N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 4/25/2014 | 66VAK99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 11/27/2013 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/6/2013 | 66YAL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/19/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 3/8/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 9/10/2010 | 60SBL99ANTACID, N.E.C. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 8/31/2010 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/9/2009 | 65RBL18SODIUM BICARBONATE (REPLENISHER) | Chicago District Office (CHI-DO) | |
| 10/30/2009 | 61VBL99ANTI-FLATULENT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/24/2009 | 54FYL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/29/2007 | 66VDK99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/3/2006 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/30/2006 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 11/9/2005 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/9/2005 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Promed Laboratories's FDA import refusal history?
Promed Laboratories (FEI: 3010380229) has 23 FDA import refusal record(s) in our database, spanning from 7/9/2005 to 2/4/2019.
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. Promed Laboratories's FEI number is 3010380229.
What types of violations has Promed Laboratories received?
Promed Laboratories has been cited for 6 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 Promed Laboratories come from?
All FDA import refusal data for Promed 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.