Qualpro Diagnostics

⚠️ Moderate Risk

FEI: 3003275790 • Verna Goa • INDIA

FEI

FEI Number

3003275790

📍

Location

Verna Goa

🇮🇳

Country

INDIA

🏢

Address

Plot Nos. 88 & 89, 1st Floor Phase Ii C, Verna Industrial Estate, Verna Goa, , India

Moderate Risk

FDA Import Risk Assessment

32.3

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

3/7/2012

Latest Refusal

1/4/2011

Earliest Refusal

Score Breakdown

Violation Severity

40.8×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

59.7×10%

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

1187×

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).

3416×

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
3/7/2012	57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.	118NOT LISTED	Florida District Office (FLA-DO)
1/4/2011	88LDTREAGENT, GENERAL PURPOSE	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
1/4/2011	88LDTREAGENT, GENERAL PURPOSE	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
1/4/2011	81MTNTEST, SYPHILIS, TREPONEMAL	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
1/4/2011	88LDTREAGENT, GENERAL PURPOSE	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
1/4/2011	81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
1/4/2011	81MTNTEST, SYPHILIS, TREPONEMAL	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Qualpro Diagnostics's FDA import refusal history?

Qualpro Diagnostics (FEI: 3003275790) has 7 FDA import refusal record(s) in our database, spanning from 1/4/2011 to 3/7/2012.

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. Qualpro Diagnostics's FEI number is 3003275790.

What types of violations has Qualpro Diagnostics received?

Qualpro Diagnostics 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 Qualpro Diagnostics come from?

All FDA import refusal data for Qualpro Diagnostics 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.