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SARM HEALTHCARE INSTRUMENT

⚠️ Moderate Risk

FEI: 3027119394 • Sialkot • PAKISTAN

FEI

FEI Number

3027119394

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

Kingra Rd, Langrewali, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

41.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/28/2023
Latest Refusal
4/28/2023
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
45.3×20%
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

27801×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
4/28/2023
87HXPINSTRUMENT, BENDING OR CONTOURING
2780DEVICEGMPS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SARM HEALTHCARE INSTRUMENT's FDA import refusal history?

SARM HEALTHCARE INSTRUMENT (FEI: 3027119394) has 1 FDA import refusal record(s) in our database, spanning from 4/28/2023 to 4/28/2023.

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. SARM HEALTHCARE INSTRUMENT's FEI number is 3027119394.

What types of violations has SARM HEALTHCARE INSTRUMENT received?

SARM HEALTHCARE INSTRUMENT has been cited for 1 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 SARM HEALTHCARE INSTRUMENT come from?

All FDA import refusal data for SARM HEALTHCARE INSTRUMENT 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.