Sugih Instrumendo Abadi, PT.
⚠️ Moderate Risk
FEI: 3002118752 • Jawa Barat • INDONESIA
FEI Number
3002118752
Location
Jawa Barat
Country
INDONESIAAddress
Jl. Tembokan Rt. 1/01, Ds. Cipeundeuy, , Padalarang, Jawa Barat, , 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
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Sugih Instrumendo Abadi, PT.'s FDA import refusal history?
Sugih Instrumendo Abadi, PT. (FEI: 3002118752) has 2 FDA import refusal record(s) in our database, spanning from 5/11/2002 to 7/18/2013.
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. Sugih Instrumendo Abadi, PT.'s FEI number is 3002118752.
What types of violations has Sugih Instrumendo Abadi, PT. received?
Sugih Instrumendo Abadi, PT. 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 Sugih Instrumendo Abadi, PT. come from?
All FDA import refusal data for Sugih Instrumendo Abadi, PT. 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.