PT. Tempo Scan Pacific
⚠️ Moderate Risk
FEI: 3002624249 • 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/27/2014 | 64LBJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | Cincinnati District Office (CIN-DO) | |
| 2/27/2014 | 64LBJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Cincinnati District Office (CIN-DO) | |
| 2/27/2014 | 64LBJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Cincinnati District Office (CIN-DO) | |
| 9/8/2010 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Southwest Import District Office (SWI-DO) | |
| 4/13/2010 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 483DRUG NAME | New York District Office (NYK-DO) |
| 4/13/2010 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 483DRUG NAME | New York District Office (NYK-DO) |
| 1/4/2002 | 66BIY99STIMULANT N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is PT. Tempo Scan Pacific's FDA import refusal history?
PT. Tempo Scan Pacific (FEI: 3002624249) has 7 FDA import refusal record(s) in our database, spanning from 1/4/2002 to 2/27/2014.
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. Tempo Scan Pacific's FEI number is 3002624249.
What types of violations has PT. Tempo Scan Pacific received?
PT. Tempo Scan Pacific 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. Tempo Scan Pacific come from?
All FDA import refusal data for PT. Tempo Scan Pacific 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.