Csc Pharmaceutical
⚠️ High Risk
FEI: 3004037093 • Mumbai, Maharashtra • INDIA
FEI Number
3004037093
Location
Mumbai, Maharashtra
Country
INDIAAddress
64 - A Jasraj Bhavan, , Mumbai, Maharashtra, 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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 |
|---|---|---|---|
| 8/18/2003 | 63FIP07DOBUTAMINE (CARDIOTONIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 56BIP05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 56BCP03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 56KCP10CHLORAMPHENICOL | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 56BCP09AMPICILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 61LCP08HEPARIN SODIUM (ANTI-COAGULANT) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 64LCP41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 64GIP99ESTROGEN N.E.C. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 61WIP04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 53BI03BATH CAPSULES (BATH PREPARATIONS) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 60SCA25RANITIDINE HYDROCHLORIDE (ANTACID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 62GIP59PIROXICAM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 56BCP56PIPERACILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 56BCP56PIPERACILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 65JIP19LYNESTRENOL (PROGESTIN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 60CIP53XYLOMETAZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Csc Pharmaceutical's FDA import refusal history?
Csc Pharmaceutical (FEI: 3004037093) has 23 FDA import refusal record(s) in our database, spanning from 8/18/2003 to 8/18/2003.
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. Csc Pharmaceutical's FEI number is 3004037093.
What types of violations has Csc Pharmaceutical received?
Csc Pharmaceutical 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 Csc Pharmaceutical come from?
All FDA import refusal data for Csc Pharmaceutical 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.