Calcutta Chemical Co Ltd
⚠️ Moderate Risk
FEI: 3003283822 • Kolkata, West Bengal • INDIA
FEI Number
3003283822
Location
Kolkata, West Bengal
Country
INDIAAddress
28 C N Roy Road, , Kolkata, West Bengal, 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.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/9/2005 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/9/2005 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/21/2004 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southwest Imports (DSWI) | |
| 8/27/2003 | 63RAN04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Calcutta Chemical Co Ltd's FDA import refusal history?
Calcutta Chemical Co Ltd (FEI: 3003283822) has 4 FDA import refusal record(s) in our database, spanning from 8/27/2003 to 7/9/2005.
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. Calcutta Chemical Co Ltd's FEI number is 3003283822.
What types of violations has Calcutta Chemical Co Ltd received?
Calcutta Chemical Co Ltd has been cited for 6 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 Calcutta Chemical Co Ltd come from?
All FDA import refusal data for Calcutta Chemical Co 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.