MEDGEL PRIVATE LIMITED
⚠️ Moderate Risk
FEI: 3010165392 • Dhar, Madhya Pradesh • INDIA
FEI Number
3010165392
Location
Dhar, Madhya Pradesh
Country
INDIAAddress
Special Economic Zone, Plot No.-19-20, Pharma Zone, Phase-II, Sector-III, , Pithampur, Dhar, 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
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
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 |
|---|---|---|---|
| 11/3/2023 | 60LBH01ACETAMINOPHEN (ANALGESIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/3/2023 | 61XAL18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 6/14/2023 | 61XAL18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 6/14/2023 | 61XAL18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/5/2016 | 63HAE23SENNOSIDES A AND B (CATHARTIC) | Division of Northern Border Imports (DNBI) | |
| 1/5/2016 | 64HAE02GUAIFENESIN (EXPECTORANT) | Division of Northern Border Imports (DNBI) | |
| 1/5/2016 | 61VAE01SIMETHICONE (ANTI-FLATULENT) | Division of Northern Border Imports (DNBI) | |
| 1/5/2016 | 62UAE11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | Division of Northern Border Imports (DNBI) | |
| 1/5/2016 | 61XAE18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/5/2016 | 60LAE01ACETAMINOPHEN (ANALGESIC) | Division of Northern Border Imports (DNBI) | |
| 9/12/2014 | 60LBH01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 6/19/2012 | 66CIH01DIOCTYL CALCIUM SULFOSUCCINATE (STOOL SOFTENER) | New Orleans District Office (NOL-DO) | |
| 6/19/2012 | 60LBH01ACETAMINOPHEN (ANALGESIC) | New Orleans District Office (NOL-DO) | |
| 6/19/2012 | 60LBH01ACETAMINOPHEN (ANALGESIC) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is MEDGEL PRIVATE LIMITED's FDA import refusal history?
MEDGEL PRIVATE LIMITED (FEI: 3010165392) has 14 FDA import refusal record(s) in our database, spanning from 6/19/2012 to 11/3/2023.
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. MEDGEL PRIVATE LIMITED's FEI number is 3010165392.
What types of violations has MEDGEL PRIVATE LIMITED received?
MEDGEL PRIVATE LIMITED 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 MEDGEL PRIVATE LIMITED come from?
All FDA import refusal data for MEDGEL 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.