Global Calcium Pvt Ltd
⚠️ High Risk
FEI: 3006671686 • Bangalore, Karnataka • INDIA
FEI Number
3006671686
Location
Bangalore, Karnataka
Country
INDIAAddress
2nd Floor, 1 17'th Main Road, Bangalore, Karnataka, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/24/2014 | 65RCK04CALCIUM GLUCONATE (REPLENISHER) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 10/16/2013 | 54BBZ08MAGNESIUM (MINERAL) | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 10/16/2013 | 54BBR13ZINC (MINERAL) | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 10/16/2013 | 54BBR13ZINC (MINERAL) | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 10/16/2013 | 54BBZ01CALCIUM (MINERAL) | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 10/16/2013 | 54BBZ08MAGNESIUM (MINERAL) | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 10/16/2013 | 54BBR09MANGANESE (MINERAL) | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 10/16/2013 | 65RAR05CALCIUM LACTATE (REPLENISHER) | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 10/16/2013 | 54BBZ01CALCIUM (MINERAL) | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 10/16/2013 | 54BBZ01CALCIUM (MINERAL) | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 7/31/2012 | 65RCX04CALCIUM GLUCONATE (REPLENISHER) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Global Calcium Pvt Ltd's FDA import refusal history?
Global Calcium Pvt Ltd (FEI: 3006671686) has 11 FDA import refusal record(s) in our database, spanning from 7/31/2012 to 1/24/2014.
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. Global Calcium Pvt Ltd's FEI number is 3006671686.
What types of violations has Global Calcium Pvt Ltd received?
Global Calcium Pvt 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 Global Calcium Pvt Ltd come from?
All FDA import refusal data for Global Calcium 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.