PHIACADEMY GMBH
⚠️ High Risk
FEI: 3012976775 • Vienna • AUSTRIA
FEI Number
3012976775
Location
Vienna
Country
AUSTRIAAddress
Gartengasse 88/1050, , Vienna, , Austria
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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.
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).
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).
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/5/2018 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/5/2018 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/5/2018 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/5/2018 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Southeast Imports (DSEI) | |
| 8/7/2018 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 8/7/2018 | 53YF04TATTOO INK | Division of Northern Border Imports (DNBI) | |
| 7/27/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 7/13/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 6/26/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 6/21/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 6/19/2018 | 53YY04TATTOO INK | Division of Southeast Imports (DSEI) | |
| 6/15/2018 | 53YD04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/18/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 5/16/2018 | 53CY08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 5/15/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 5/9/2018 | 53YD04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 4/30/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 3/28/2018 | 53CD14EYELASH AND EYEBROW TREATMENTS-GEL, OIL, PRIMER, CONDITIONERS, SERUM, FORTIFIERS (EYE MAKEUP PREPARA | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 3/28/2018 | 53YC04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 3/28/2018 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 3/28/2018 | 53CD14EYELASH AND EYEBROW TREATMENTS-GEL, OIL, PRIMER, CONDITIONERS, SERUM, FORTIFIERS (EYE MAKEUP PREPARA | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 3/28/2018 | 53CD14EYELASH AND EYEBROW TREATMENTS-GEL, OIL, PRIMER, CONDITIONERS, SERUM, FORTIFIERS (EYE MAKEUP PREPARA | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 3/22/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 3/21/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 3/7/2018 | 53YD04TATTOO INK | Division of Southwest Imports (DSWI) | |
| 3/5/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/20/2018 | 53YD04TATTOO INK | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 2/12/2018 | 53CY08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 2/12/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 2/12/2018 | 53CY08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 2/12/2018 | 53YY04TATTOO INK | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 2/12/2018 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 2/12/2018 | 53YF04TATTOO INK | Division of Northern Border Imports (DNBI) | |
| 2/12/2018 | 53CF06MASCARA (EYE MAKEUP PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 2/12/2018 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 6/30/2017 | 53YD04TATTOO INK | Division of Northern Border Imports (DNBI) | |
| 5/23/2017 | 53YY04TATTOO INK | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 5/23/2017 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is PHIACADEMY GMBH's FDA import refusal history?
PHIACADEMY GMBH (FEI: 3012976775) has 46 FDA import refusal record(s) in our database, spanning from 5/23/2017 to 10/5/2018.
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. PHIACADEMY GMBH's FEI number is 3012976775.
What types of violations has PHIACADEMY GMBH received?
PHIACADEMY GMBH has been cited for 11 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 PHIACADEMY GMBH come from?
All FDA import refusal data for PHIACADEMY GMBH 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.