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Health Star Hollow Ware

⚠️ Moderate Risk

FEI: 3008447676 • Saikot • PAKISTAN

FEI

FEI Number

3008447676

📍

Location

Saikot

🇵🇰

Country

PAKISTAN
🏢

Address

Industries Aiman Abad Road, , Saikot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
3/28/2017
Latest Refusal
3/28/2017
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

27802×

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
3/28/2017
79LRPTRAY, SURGICAL
2780DEVICEGMPS
New Orleans District Office (NOL-DO)
3/28/2017
80FMHCONTAINER, SPECIMEN
2780DEVICEGMPS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Health Star Hollow Ware's FDA import refusal history?

Health Star Hollow Ware (FEI: 3008447676) has 2 FDA import refusal record(s) in our database, spanning from 3/28/2017 to 3/28/2017.

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. Health Star Hollow Ware's FEI number is 3008447676.

What types of violations has Health Star Hollow Ware received?

Health Star Hollow Ware 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 Health Star Hollow Ware come from?

All FDA import refusal data for Health Star Hollow Ware 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.