Wyeth Ilaclari As

⚠️ Moderate Risk

FEI: 3003669791 • Esentepe Istanbul • TURKEY

FEI

FEI Number

3003669791

📍

Location

Esentepe Istanbul

🇹🇷

Country

TURKEY

🏢

Address

Maya Akar Ctr, , Esentepe Istanbul, , Turkey

Moderate Risk

FDA Import Risk Assessment

45.1

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

6/18/2004

Latest Refusal

10/8/2002

Earliest Refusal

Score Breakdown

Violation Severity

43.0×40%

Refusal Volume

59.7×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

47231×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

1189×

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).

2377×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

752×

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).

3411×

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).

Refusal History

Date	Product	Violations	Division
6/18/2004	60LCA99ANALGESIC, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
6/18/2004	60LCA80ERGOTAMINE TARTRATE (ANALGESIC)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
11/26/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	472NO ENGLISH	New York District Office (NYK-DO)
10/24/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	118NOT LISTED 237NO PMA 341REGISTERED	Cincinnati District Office (CIN-DO)
10/8/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	118NOT LISTED 237NO PMA	Cincinnati District Office (CIN-DO)
10/8/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	118NOT LISTED 237NO PMA	Cincinnati District Office (CIN-DO)
10/8/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	118NOT LISTED 237NO PMA	Cincinnati District Office (CIN-DO)
10/8/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	118NOT LISTED 237NO PMA	Cincinnati District Office (CIN-DO)
10/8/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	118NOT LISTED 237NO PMA	Cincinnati District Office (CIN-DO)
10/8/2002	89MOZACID, HYALURONIC, INTRAARTICULAR	118NOT LISTED 237NO PMA	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Wyeth Ilaclari As's FDA import refusal history?

Wyeth Ilaclari As (FEI: 3003669791) has 40 FDA import refusal record(s) in our database, spanning from 10/8/2002 to 6/18/2004.

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. Wyeth Ilaclari As's FEI number is 3003669791.

What types of violations has Wyeth Ilaclari As received?

Wyeth Ilaclari As has been cited for 5 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 Wyeth Ilaclari As come from?

All FDA import refusal data for Wyeth Ilaclari As 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.