SciTech Healthcare Pvt Ltd AKA Cipex Specialties
⚠️ Moderate Risk
FEI: 3004659169 • Mumbai, Maharashtra • INDIA
FEI Number
3004659169
Location
Mumbai, Maharashtra
Country
INDIAAddress
Jijamata Marg, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/7/2006 | 62UIS20DEXTROMETHORPHAN POLISTIREX (ANTI-TUSSIVE/COLD) | New Orleans District Office (NOL-DO) | |
| 8/19/2005 | 56KDS11CHLORAMPHENICOL PALMITATE | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/28/2005 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is SciTech Healthcare Pvt Ltd AKA Cipex Specialties's FDA import refusal history?
SciTech Healthcare Pvt Ltd AKA Cipex Specialties (FEI: 3004659169) has 3 FDA import refusal record(s) in our database, spanning from 3/28/2005 to 12/7/2006.
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. SciTech Healthcare Pvt Ltd AKA Cipex Specialties's FEI number is 3004659169.
What types of violations has SciTech Healthcare Pvt Ltd AKA Cipex Specialties received?
SciTech Healthcare Pvt Ltd AKA Cipex Specialties 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 SciTech Healthcare Pvt Ltd AKA Cipex Specialties come from?
All FDA import refusal data for SciTech Healthcare Pvt Ltd AKA Cipex Specialties 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.