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MS SABRO SURGICAL INSTRUMENTS CO

⚠️ Moderate Risk

FEI: 3016425294 • Delhi • INDIA

FEI

FEI Number

3016425294

📍

Location

Delhi

🇮🇳

Country

INDIA
🏢

Address

1620 2nd Floor Outram L, , Delhi, , India

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/19/2022
Latest Refusal
9/19/2022
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
19.7×20%
Frequency
10.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

1181×

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
9/19/2022
79HTDFORCEPS
118NOT LISTED
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is MS SABRO SURGICAL INSTRUMENTS CO's FDA import refusal history?

MS SABRO SURGICAL INSTRUMENTS CO (FEI: 3016425294) has 1 FDA import refusal record(s) in our database, spanning from 9/19/2022 to 9/19/2022.

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. MS SABRO SURGICAL INSTRUMENTS CO's FEI number is 3016425294.

What types of violations has MS SABRO SURGICAL INSTRUMENTS CO received?

MS SABRO SURGICAL INSTRUMENTS CO 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 MS SABRO SURGICAL INSTRUMENTS CO come from?

All FDA import refusal data for MS SABRO SURGICAL INSTRUMENTS CO 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.