Pt Sekai Indonesia
⚠️ Moderate Risk
FEI: 3004975490 • Bekasi, Jabotabek • INDONESIA
FEI Number
3004975490
Location
Bekasi, Jabotabek
Country
INDONESIAAddress
Jln. Siliwangi, , Bekasi, Jabotabek, Indonesia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
INCONSPICU
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/10/2014 | 53PD99OTHER COSMETIC RAW MATERIALS, N.E.C. | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 6/9/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 4/23/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 256INCONSPICU | Cincinnati District Office (CIN-DO) |
| 4/23/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 256INCONSPICU | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Pt Sekai Indonesia's FDA import refusal history?
Pt Sekai Indonesia (FEI: 3004975490) has 4 FDA import refusal record(s) in our database, spanning from 4/23/2014 to 6/10/2014.
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 Sekai Indonesia's FEI number is 3004975490.
What types of violations has Pt Sekai Indonesia received?
Pt Sekai Indonesia has been cited for 3 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 Sekai Indonesia come from?
All FDA import refusal data for Pt Sekai Indonesia 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.