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Abbott Laboratories (M) Sdn. Bhd.

⚠️ Moderate Risk

FEI: 2000015886 • Shah Alam, Selangor • MALAYSIA

FEI

FEI Number

2000015886

📍

Location

Shah Alam, Selangor

🇲🇾

Country

MALAYSIA
🏢

Address

No.22, Jalan Pemaju U1/15, Sekysen U1, HICOM - Glenmarie Industrial Park, Shah Alam, Selangor, Malaysia

Moderate Risk

FDA Import Risk Assessment

33.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/31/2023
Latest Refusal
5/31/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
47.1×20%
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

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
5/31/2023
64EDH02PANCREATIN (ENZYME)
3280FRNMFGREG
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Abbott Laboratories (M) Sdn. Bhd.'s FDA import refusal history?

Abbott Laboratories (M) Sdn. Bhd. (FEI: 2000015886) has 1 FDA import refusal record(s) in our database, spanning from 5/31/2023 to 5/31/2023.

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. Abbott Laboratories (M) Sdn. Bhd.'s FEI number is 2000015886.

What types of violations has Abbott Laboratories (M) Sdn. Bhd. received?

Abbott Laboratories (M) Sdn. Bhd. 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 Abbott Laboratories (M) Sdn. Bhd. come from?

All FDA import refusal data for Abbott Laboratories (M) Sdn. Bhd. 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.