Cadila Pharmaceuticals
⚠️ Moderate Risk
FEI: 1000640928 • Ahmedabad • INDIA
FEI Number
1000640928
Location
Ahmedabad
Country
INDIAAddress
Mithakhali Six Rd, , Ahmedabad, , 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
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/24/2014 | 60LCY05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/12/2012 | 62VCZ18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/5/2009 | 60CBR09PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/26/2007 | 62ODB34FOSINOPRIL SODIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/10/2006 | 61LIY14CHLORHEXIDINE GLUCONATE | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/9/2006 | 61XDK41ACRIVASTINE/PSEUDOEPHEDRINE HCL (ANTI-HISTAMINIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Cadila Pharmaceuticals's FDA import refusal history?
Cadila Pharmaceuticals (FEI: 1000640928) has 6 FDA import refusal record(s) in our database, spanning from 8/9/2006 to 11/24/2014.
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. Cadila Pharmaceuticals's FEI number is 1000640928.
What types of violations has Cadila Pharmaceuticals received?
Cadila Pharmaceuticals 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 Cadila Pharmaceuticals come from?
All FDA import refusal data for Cadila 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.