PT. GALENIUM PHARMASIA LABORATORIES
⚠️ Moderate Risk
FEI: 3005157144 • Jakarta Selatan, Dki Jakarta • INDONESIA
FEI Number
3005157144
Location
Jakarta Selatan, Dki Jakarta
Country
INDONESIAAddress
Jln. Aditiawarman I, , Jakarta Selatan, Dki Jakarta, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2013 | 66VBU99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 2/14/2011 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/14/2011 | 53LK03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/5/2009 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is PT. GALENIUM PHARMASIA LABORATORIES's FDA import refusal history?
PT. GALENIUM PHARMASIA LABORATORIES (FEI: 3005157144) has 4 FDA import refusal record(s) in our database, spanning from 1/5/2009 to 1/31/2013.
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. PT. GALENIUM PHARMASIA LABORATORIES's FEI number is 3005157144.
What types of violations has PT. GALENIUM PHARMASIA LABORATORIES received?
PT. GALENIUM PHARMASIA LABORATORIES has been cited for 4 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. GALENIUM PHARMASIA LABORATORIES come from?
All FDA import refusal data for PT. GALENIUM PHARMASIA LABORATORIES 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.