Coast Enterprises Sa
⚠️ High Risk
FEI: 3007857015 • Ciudad De Colon, Colon • PANAMA
FEI Number
3007857015
Location
Ciudad De Colon, Colon
Country
PANAMAAddress
Zona Libre De Colon Bldg 45, , Ciudad De Colon, Colon, 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
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).
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).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2017 | 60LAK99ANALGESIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 60LAK99ANALGESIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 60LAZ99ANALGESIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 60LAZ99ANALGESIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 60LAZ99ANALGESIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 66CAH99STOOL SOFTENER N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 60LAY99ANALGESIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 60SAK99ANTACID, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 60SAK99ANTACID, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 60SAK99ANTACID, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 60SAY99ANTACID, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 60SAY99ANTACID, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 60SAY99ANTACID, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 60SAY99ANTACID, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 60SAY99ANTACID, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 62GAY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 66CAH99STOOL SOFTENER N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 66CAH99STOOL SOFTENER N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2017 | 54IYY99FIBER, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/3/2010 | 60LAK99ANALGESIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/3/2010 | 60LAK99ANALGESIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/3/2010 | 60LAZ99ANALGESIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/22/2010 | 60LAZ99ANALGESIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/22/2010 | 60SAK99ANTACID, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/8/2010 | 53DD02PERFUMES (FRAGRANCE PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 10/8/2010 | 53EC06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Florida District Office (FLA-DO) | |
| 10/8/2010 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/8/2010 | 53LA04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/8/2010 | 53LA04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/8/2010 | 53LA04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/24/2009 | 53LH04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/24/2009 | 53HY99OTHER MANICURING PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/24/2009 | 53LF04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/24/2009 | 53LC04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/24/2009 | 53LD04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/24/2009 | 53LF04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/24/2009 | 53LD04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/24/2009 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/24/2009 | 53LH04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/24/2009 | 54IYY99FIBER, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/24/2009 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/24/2009 | 62GAY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/24/2009 | 62GAY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/24/2009 | 62GAO99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/24/2009 | 62GAY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/24/2009 | 60SAH99ANTACID, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/24/2009 | 60SAK99ANTACID, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/24/2009 | 60SAH99ANTACID, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/24/2009 | 66CAH99STOOL SOFTENER N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/24/2009 | 62GAY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Coast Enterprises Sa's FDA import refusal history?
Coast Enterprises Sa (FEI: 3007857015) has 50 FDA import refusal record(s) in our database, spanning from 11/24/2009 to 3/21/2017.
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. Coast Enterprises Sa's FEI number is 3007857015.
What types of violations has Coast Enterprises Sa received?
Coast Enterprises Sa has been cited for 4 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 Coast Enterprises Sa come from?
All FDA import refusal data for Coast Enterprises Sa 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.