NITIKA PHARMACEUTICAL SPECIALITIES PVT LTD
⚠️ Moderate Risk
FEI: 3012763572 • Nagpur-2, Maharashtra • INDIA
FEI Number
3012763572
Location
Nagpur-2, Maharashtra
Country
INDIAAddress
Block No 03 Of Plot No. 1296, 1297/08, Ward No. 03, Mouza - Waddhamana, Tah. Hingna, Amrawati Road, Nagpur-2, 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
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
Frequently Asked Questions
What is NITIKA PHARMACEUTICAL SPECIALITIES PVT LTD's FDA import refusal history?
NITIKA PHARMACEUTICAL SPECIALITIES PVT LTD (FEI: 3012763572) has 1 FDA import refusal record(s) in our database, spanning from 8/10/2010 to 8/10/2010.
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. NITIKA PHARMACEUTICAL SPECIALITIES PVT LTD's FEI number is 3012763572.
What types of violations has NITIKA PHARMACEUTICAL SPECIALITIES PVT LTD received?
NITIKA PHARMACEUTICAL SPECIALITIES PVT LTD 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 NITIKA PHARMACEUTICAL SPECIALITIES PVT LTD come from?
All FDA import refusal data for NITIKA PHARMACEUTICAL SPECIALITIES PVT 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.