Anuh Pharma Ltd
⚠️ Moderate Risk
FEI: 3006259540 • Mumbai, Maharashtra • INDIA
FEI Number
3006259540
Location
Mumbai, Maharashtra
Country
INDIAAddress
3-A, Shivsagar Estate, North Wing,, Dr Annie Besant Road, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2020 | 56IDY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/25/2016 | 56IYY25ERYTHROMYCIN ETHYLSUCCINATE (MACROLIDES) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/18/2015 | 64LDY04BETAMETHASONE ACETATE (GLUCOCORTICOID) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 4/4/2014 | 56KIR11CHLORAMPHENICOL PALMITATE | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/12/2014 | 64LAJ08BETAMETHASONE VALERATE (GLUCOCORTICOID) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/7/2014 | 64LAJ08BETAMETHASONE VALERATE (GLUCOCORTICOID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/4/2014 | 56KCT11CHLORAMPHENICOL PALMITATE | New Orleans District Office (NOL-DO) | |
| 5/30/2013 | 64LAJ08BETAMETHASONE VALERATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2013 | 56KCT11CHLORAMPHENICOL PALMITATE | Atlanta District Office (ATL-DO) | |
| 3/25/2013 | 61HAS27PYRAZINAMIDE (ANTI-BACTERIAL) | Detroit District Office (DET-DO) | |
| 1/31/2013 | 56KJT11CHLORAMPHENICOL PALMITATE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/31/2011 | 64LAJ08BETAMETHASONE VALERATE (GLUCOCORTICOID) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/16/2011 | 64LAJ08BETAMETHASONE VALERATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/2/2011 | 56ICS35ERYTHROMYCIN STEARATE (MACROLIDES) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/10/2011 | 56IYY25ERYTHROMYCIN ETHYLSUCCINATE (MACROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/5/2009 | 56ICS35ERYTHROMYCIN STEARATE (MACROLIDES) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/30/2007 | 64LAJ08BETAMETHASONE VALERATE (GLUCOCORTICOID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/25/2007 | 61FAY33ERTHROMYCIN ETHYLCARBONATE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/9/2005 | 56ICS35ERYTHROMYCIN STEARATE (MACROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Anuh Pharma Ltd's FDA import refusal history?
Anuh Pharma Ltd (FEI: 3006259540) has 19 FDA import refusal record(s) in our database, spanning from 6/9/2005 to 8/22/2020.
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. Anuh Pharma Ltd's FEI number is 3006259540.
What types of violations has Anuh Pharma Ltd received?
Anuh Pharma Ltd has been cited for 3 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 Anuh Pharma Ltd come from?
All FDA import refusal data for Anuh Pharma 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.