Badrivishal Chemicals & Pharmaceuticals
⚠️ Moderate Risk
FEI: 3004058356 • Dist. Pune • INDIA
FEI Number
3004058356
Location
Dist. Pune
Country
INDIAAddress
Gat No. 29, Village Jambwade (Induri), Post Sudumbre, Taluka Maval, Dist. Pune, , 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).
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
Frequently Asked Questions
What is Badrivishal Chemicals & Pharmaceuticals's FDA import refusal history?
Badrivishal Chemicals & Pharmaceuticals (FEI: 3004058356) has 3 FDA import refusal record(s) in our database, spanning from 11/29/2011 to 2/15/2017.
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. Badrivishal Chemicals & Pharmaceuticals's FEI number is 3004058356.
What types of violations has Badrivishal Chemicals & Pharmaceuticals received?
Badrivishal Chemicals & Pharmaceuticals 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 Badrivishal Chemicals & Pharmaceuticals come from?
All FDA import refusal data for Badrivishal Chemicals & Pharmaceuticals 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.