Eagle Indo Pharma, PT
⚠️ Moderate Risk
FEI: 1000286079 • Tangerang, Jabotabek • INDONESIA
FEI Number
1000286079
Location
Tangerang, Jabotabek
Country
INDONESIAAddress
Km. 1.1 Alam Jaya, Jl Raya Prabu Siliwangi, Tangerang, 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
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/23/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/23/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/23/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 7/11/2016 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 8/2/2006 | 60LAJ99ANALGESIC, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Eagle Indo Pharma, PT's FDA import refusal history?
Eagle Indo Pharma, PT (FEI: 1000286079) has 5 FDA import refusal record(s) in our database, spanning from 8/2/2006 to 5/23/2017.
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. Eagle Indo Pharma, PT's FEI number is 1000286079.
What types of violations has Eagle Indo Pharma, PT received?
Eagle Indo Pharma, 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 Eagle Indo Pharma, PT come from?
All FDA import refusal data for Eagle Indo Pharma, 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.