Parbel Inc
⚠️ Moderate Risk
FEI: 3004823826 • Miami, FL • UNITED STATES
FEI Number
3004823826
Location
Miami, FL
Country
UNITED STATESAddress
5200 Lagoon Drive, , Miami, FL, United States
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
HELD INSAN
The cosmetic appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/23/2008 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 4/25/2005 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 313HELD INSAN | Seattle District Office (SEA-DO) |
| 4/25/2005 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 313HELD INSAN | Seattle District Office (SEA-DO) |
| 4/25/2005 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 313HELD INSAN | Seattle District Office (SEA-DO) |
| 4/25/2005 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 313HELD INSAN | Seattle District Office (SEA-DO) |
| 4/25/2005 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 313HELD INSAN | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Parbel Inc's FDA import refusal history?
Parbel Inc (FEI: 3004823826) has 6 FDA import refusal record(s) in our database, spanning from 4/25/2005 to 12/23/2008.
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. Parbel Inc's FEI number is 3004823826.
What types of violations has Parbel Inc received?
Parbel Inc 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 Parbel Inc come from?
All FDA import refusal data for Parbel Inc 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.