Siemens Healthcare Diagnostics, Inc.

⚠️ Moderate Risk

FEI: 1219913 • East Walpole, MA • UNITED STATES

FEI

FEI Number

1219913

📍

Location

East Walpole, MA

🇺🇸

Country

UNITED STATES

🏢

Address

333 Coney St, , East Walpole, MA, United States

Moderate Risk

FDA Import Risk Assessment

46.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/4/2018

Latest Refusal

12/4/2018

Earliest Refusal

Score Breakdown

Violation Severity

70.0×40%

Refusal Volume

35.3×30%

Recency

0.0×20%

Frequency

80.0×10%

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

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.

4798×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

Date	Product	Violations	Division
12/4/2018	83LOLHEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)	16DIRECTIONS 479DV QUALITY	Division of Southeast Imports (DSEI)
12/4/2018	75JHIRADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN	16DIRECTIONS 479DV QUALITY	Division of Southeast Imports (DSEI)
12/4/2018	82MZFTEST, HIV DETECTION	16DIRECTIONS 479DV QUALITY	Division of Southeast Imports (DSEI)
12/4/2018	75CFTRADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)	16DIRECTIONS 479DV QUALITY	Division of Southeast Imports (DSEI)
12/4/2018	78KNWINSTRUMENT, BIOPSY	16DIRECTIONS 479DV QUALITY	Division of Southeast Imports (DSEI)
12/4/2018	75CDPRADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE	16DIRECTIONS 479DV QUALITY	Division of Southeast Imports (DSEI)
12/4/2018	75CGNACID, FOLIC, RADIOIMMUNOASSAY	16DIRECTIONS 479DV QUALITY	Division of Southeast Imports (DSEI)
12/4/2018	75NBCTEST, NATRIURETIC PEPTIDE	16DIRECTIONS 479DV QUALITY	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Siemens Healthcare Diagnostics, Inc.'s FDA import refusal history?

Siemens Healthcare Diagnostics, Inc. (FEI: 1219913) has 8 FDA import refusal record(s) in our database, spanning from 12/4/2018 to 12/4/2018.

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. Siemens Healthcare Diagnostics, Inc.'s FEI number is 1219913.

What types of violations has Siemens Healthcare Diagnostics, Inc. received?

Siemens Healthcare Diagnostics, Inc. 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 Siemens Healthcare Diagnostics, Inc. come from?

All FDA import refusal data for Siemens Healthcare Diagnostics, Inc. 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.