Smithkline Beecham Costa Rica S.A.
⚠️ Moderate Risk
FEI: 3002952995 • San Jose • COSTA RICA
FEI Number
3002952995
Location
San Jose
Country
COSTA RICAAddress
400 M Exte De La Rot.La Bandera, , San Jose, , Costa Rica
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).
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 |
|---|---|---|---|
| 4/9/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/6/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/6/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/18/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/10/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/26/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/5/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/5/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/17/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/17/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/25/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/22/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/4/2001 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/6/2001 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Smithkline Beecham Costa Rica S.A.'s FDA import refusal history?
Smithkline Beecham Costa Rica S.A. (FEI: 3002952995) has 16 FDA import refusal record(s) in our database, spanning from 11/6/2001 to 4/9/2003.
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. Smithkline Beecham Costa Rica S.A.'s FEI number is 3002952995.
What types of violations has Smithkline Beecham Costa Rica S.A. received?
Smithkline Beecham Costa Rica S.A. 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 Smithkline Beecham Costa Rica S.A. come from?
All FDA import refusal data for Smithkline Beecham Costa Rica S.A. 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.