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Pt Badar Jaya Sakti

⚠️ High Risk

FEI: 3011555639 • Tangerang, Jabotabek • INDONESIA

FEI

FEI Number

3011555639

📍

Location

Tangerang, Jabotabek

🇮🇩

Country

INDONESIA
🏢

Address

Rt 01, No 156 Jln. Setia Raya; AREN, Tangerang, Jabotabek, Indonesia

High Risk

FDA Import Risk Assessment

50.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

6
Total Refusals
2
Unique Violations
1/7/2016
Latest Refusal
8/12/2015
Earliest Refusal

Score Breakdown

Violation Severity
86.7×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

754×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

21202×

UNSFDIETSP

The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

Refusal History

DateProductViolationsDivision
1/7/2016
53PY99OTHER COSMETIC RAW MATERIALS, N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
1/7/2016
53PY99OTHER COSMETIC RAW MATERIALS, N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
1/7/2016
53PY99OTHER COSMETIC RAW MATERIALS, N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
1/7/2016
53PY99OTHER COSMETIC RAW MATERIALS, N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
9/22/2015
54YY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2120UNSFDIETSP
Cincinnati District Office (CIN-DO)
8/12/2015
54YY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2120UNSFDIETSP
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Pt Badar Jaya Sakti's FDA import refusal history?

Pt Badar Jaya Sakti (FEI: 3011555639) has 6 FDA import refusal record(s) in our database, spanning from 8/12/2015 to 1/7/2016.

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. Pt Badar Jaya Sakti's FEI number is 3011555639.

What types of violations has Pt Badar Jaya Sakti received?

Pt Badar Jaya Sakti 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 Pt Badar Jaya Sakti come from?

All FDA import refusal data for Pt Badar Jaya Sakti 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.