Otc Pharma Interna
⚠️ Moderate Risk
FEI: 3004188169 • Gorinchem, Zuid-Holland • NETHERLANDS
FEI Number
3004188169
Location
Gorinchem, Zuid-Holland
Country
NETHERLANDSAddress
Edisonweg 22, , Gorinchem, Zuid-Holland, Netherlands
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
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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 |
|---|---|---|---|
| 3/28/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Florida District Office (FLA-DO) |
| 3/28/2013 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 474COSMETLBLG | Florida District Office (FLA-DO) |
| 3/28/2013 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 3/28/2013 | 54YEH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Otc Pharma Interna's FDA import refusal history?
Otc Pharma Interna (FEI: 3004188169) has 4 FDA import refusal record(s) in our database, spanning from 3/28/2013 to 3/28/2013.
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. Otc Pharma Interna's FEI number is 3004188169.
What types of violations has Otc Pharma Interna received?
Otc Pharma Interna 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 Otc Pharma Interna come from?
All FDA import refusal data for Otc Pharma Interna 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.