Hetero Drugs Ltd
⚠️ Moderate Risk
FEI: 3005185776 • Hyderabad, Telangana • INDIA
FEI Number
3005185776
Location
Hyderabad, Telangana
Country
INDIAAddress
7 1 Hetero House # 8 - 3 - 166, , Hyderabad, Telangana, 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
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.
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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/14/2011 | 66NAA04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/15/2011 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/6/2008 | 62VIY23DIDANOSINE (ANTI-VIRAL) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 10/4/2007 | 66NDZ06ARIPIPRAZOLE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | New Orleans District Office (NOL-DO) | |
| 5/23/2007 | 61WAY46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 1/10/2006 | 62VCR42VALACYCLOVIR HCL (ANTI-VIRAL) | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 6/22/2005 | 66NIR05ZIPRASIDONE HCI (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/19/2005 | 61NDR83ESCITALOPRAM OXALATE | New York District Office (NYK-DO) | |
| 5/19/2005 | 61MCR42LEVETIRACETAM (ANTI-CONVULSANT) | New York District Office (NYK-DO) | |
| 5/19/2005 | 62OCS37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/19/2005 | 61BCS04BICALUTAMIDE (ANTI-ANDROGEN) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 4/1/2005 | 61WSC52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 4/1/2005 | 61MCS42LEVETIRACETAM (ANTI-CONVULSANT) | New York District Office (NYK-DO) | |
| 2/24/2005 | 61NIZ78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | New York District Office (NYK-DO) | |
| 2/24/2005 | 61NIS83ESCITALOPRAM OXALATE | New York District Office (NYK-DO) | |
| 11/8/2004 | 62CIS99ANTI-HYPERTENSIVE N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/29/2004 | 62OIR14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/1/2004 | 62KCH10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | New York District Office (NYK-DO) | |
| 6/1/2004 | 62KCH10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | New York District Office (NYK-DO) | |
| 6/1/2004 | 62KCH10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Hetero Drugs Ltd's FDA import refusal history?
Hetero Drugs Ltd (FEI: 3005185776) has 20 FDA import refusal record(s) in our database, spanning from 6/1/2004 to 11/14/2011.
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. Hetero Drugs Ltd's FEI number is 3005185776.
What types of violations has Hetero Drugs Ltd received?
Hetero Drugs Ltd 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 Hetero Drugs Ltd come from?
All FDA import refusal data for Hetero Drugs 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.