Smihtkline Beecham International (Panama), S.A.
⚠️ High Risk
FEI: 3002825550 • Panama • PANAMA
FEI Number
3002825550
Location
Panama
Country
PANAMAAddress
Apdo Postal El Dorado 6-1697, , Panama, , Panama
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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/9/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/9/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/9/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/2/2003 | 76EFWTOOTHBRUSH, MANUAL | Florida District Office (FLA-DO) | |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/27/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/27/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/6/2003 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/6/2003 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/21/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/17/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/15/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/19/2002 | 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) |
| 11/6/2002 | 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) |
| 11/6/2002 | 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) |
| 11/6/2002 | 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) |
| 11/6/2002 | 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) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/19/2002 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 475COSMETLBLG | Florida District Office (FLA-DO) |
| 9/19/2002 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/19/2002 | 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 6/17/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/15/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Smihtkline Beecham International (Panama), S.A.'s FDA import refusal history?
Smihtkline Beecham International (Panama), S.A. (FEI: 3002825550) has 130 FDA import refusal record(s) in our database, spanning from 12/5/2001 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. Smihtkline Beecham International (Panama), S.A.'s FEI number is 3002825550.
What types of violations has Smihtkline Beecham International (Panama), S.A. received?
Smihtkline Beecham International (Panama), S.A. 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 Smihtkline Beecham International (Panama), S.A. come from?
All FDA import refusal data for Smihtkline Beecham International (Panama), 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.