Paglieri Sell System S.p.A.

⚠️ Moderate Risk

FEI: 3005004526 • Pozzolo Formigaro, Alexandria • ITALY

FEI

FEI Number

3005004526

📍

Location

Pozzolo Formigaro, Alexandria

🇮🇹

Country

ITALY

🏢

Address

Via Dell'Industria Snc, (A1), Pozzolo Formigaro, Alexandria, Italy

Moderate Risk

FDA Import Risk Assessment

43.9

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/23/2006

Latest Refusal

6/10/2005

Earliest Refusal

Score Breakdown

Violation Severity

59.4×40%

Refusal Volume

37.0×30%

Recency

0.0×20%

Frequency

90.0×10%

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

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).

168×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

Date	Product	Violations	Division
2/23/2006	63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)	118NOT LISTED	New York District Office (NYK-DO)
6/10/2005	63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
6/10/2005	63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
6/10/2005	63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
6/10/2005	63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
6/10/2005	63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
6/10/2005	63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
6/10/2005	63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
6/10/2005	63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)

Frequently Asked Questions

What is Paglieri Sell System S.p.A.'s FDA import refusal history?

Paglieri Sell System S.p.A. (FEI: 3005004526) has 9 FDA import refusal record(s) in our database, spanning from 6/10/2005 to 2/23/2006.

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. Paglieri Sell System S.p.A.'s FEI number is 3005004526.

What types of violations has Paglieri Sell System S.p.A. received?

Paglieri Sell System S.p.A. has been cited for 2 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 Paglieri Sell System S.p.A. come from?

All FDA import refusal data for Paglieri Sell System S.p.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.