Pollack International

⚠️ Moderate Risk

FEI: 3002706172 • Rosh Ha Ayin • ISRAEL

FEI

FEI Number

3002706172

📍

Location

Rosh Ha Ayin

🇮🇱

Country

ISRAEL

🏢

Address

Hamlacha 20, , Rosh Ha Ayin, , Israel

Moderate Risk

FDA Import Risk Assessment

29.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

4/1/2010

Latest Refusal

4/22/2003

Earliest Refusal

Score Breakdown

Violation Severity

41.8×40%

Refusal Volume

37.0×30%

Recency

0.0×20%

Frequency

12.9×10%

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

1188×

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).

3418×

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).

5081×

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
4/1/2010	79HRQHEMOSTAT	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
4/1/2010	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
4/1/2010	79HXDCLAMP	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
4/1/2010	80FQASCALE, SURGICAL SPONGE	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
4/1/2010	79GESBLADE, SCALPEL	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
4/1/2010	79HTDFORCEPS	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
4/1/2010	79MCZSUTURE REMOVAL KIT	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
4/1/2010	85HFWCLAMP, UMBILICAL	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
4/22/2003	85HFXCLAMP, CIRCUMCISION	508NO 510(K)	New York District Office (NYK-DO)

Frequently Asked Questions

What is Pollack International's FDA import refusal history?

Pollack International (FEI: 3002706172) has 9 FDA import refusal record(s) in our database, spanning from 4/22/2003 to 4/1/2010.

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. Pollack International's FEI number is 3002706172.

What types of violations has Pollack International received?

Pollack International 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 Pollack International come from?

All FDA import refusal data for Pollack International 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.