Evyap International Dis Ticaret A.S.
⚠️ Moderate Risk
FEI: 3008422785 • Istanbul • TURKEY
FEI Number
3008422785
Location
Istanbul
Country
TURKEYAddress
Ayazaga Mah Ayazaga Sisli 1, , Istanbul, , Turkey
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).
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).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/5/2014 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/5/2014 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/5/2014 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 1/13/2012 | 62SPL99ANTI-SEBORRHEIC N.E.C. | Detroit District Office (DET-DO) | |
| 7/22/2011 | 63RAL04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 7/22/2011 | 63RAL04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 7/22/2011 | 63RAL04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 7/22/2011 | 63RAL04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Evyap International Dis Ticaret A.S.'s FDA import refusal history?
Evyap International Dis Ticaret A.S. (FEI: 3008422785) has 8 FDA import refusal record(s) in our database, spanning from 7/22/2011 to 9/5/2014.
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. Evyap International Dis Ticaret A.S.'s FEI number is 3008422785.
What types of violations has Evyap International Dis Ticaret A.S. received?
Evyap International Dis Ticaret A.S. has been cited for 3 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 Evyap International Dis Ticaret A.S. come from?
All FDA import refusal data for Evyap International Dis Ticaret A.S. 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.