Sonia Sp Zoo
⚠️ Moderate Risk
FEI: 3007380434 • Rzeszow, Podkarpackie • POLAND
FEI Number
3007380434
Location
Rzeszow, Podkarpackie
Country
POLANDAddress
Ul. Tadeusza Boya-Zelenskiego 25, , Rzeszow, Podkarpackie, Poland
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
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
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.
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 |
|---|---|---|---|
| 2/11/2014 | 53GH01BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES) | Division of Northeast Imports (DNEI) | |
| 2/11/2014 | 53GH01BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES) | Division of Northeast Imports (DNEI) | |
| 2/11/2014 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | Division of Northeast Imports (DNEI) | |
| 2/11/2014 | 53CC07EYELASH AND EYEBROW DYE (EYE MAKEUP PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 2/11/2014 | 53CK01EYEBROW PENCIL (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 5/7/2009 | 53JY99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 471CSTIC LBLG | Chicago District Office (CHI-DO) |
| 5/7/2009 | 63R04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Chicago District Office (CHI-DO) | |
| 5/7/2009 | 53JY99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 5/7/2009 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 5/7/2009 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Sonia Sp Zoo's FDA import refusal history?
Sonia Sp Zoo (FEI: 3007380434) has 10 FDA import refusal record(s) in our database, spanning from 5/7/2009 to 2/11/2014.
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. Sonia Sp Zoo's FEI number is 3007380434.
What types of violations has Sonia Sp Zoo received?
Sonia Sp Zoo has been cited for 5 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 Sonia Sp Zoo come from?
All FDA import refusal data for Sonia Sp Zoo 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.