Oceanic S.A.
⚠️ Moderate Risk
FEI: 3002886442 • Sopot, Pomorskie • POLAND
FEI Number
3002886442
Location
Sopot, Pomorskie
Country
POLANDAddress
Ul. Wladyslawa Lokietka 58, , Sopot, Pomorskie, 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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
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 |
|---|---|---|---|
| 2/15/2024 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | Division of Northern Border Imports (DNBI) |
| 11/8/2023 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | Division of Northern Border Imports (DNBI) | |
| 11/8/2023 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | Division of Northern Border Imports (DNBI) | |
| 11/8/2023 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | Division of Northern Border Imports (DNBI) | |
| 11/8/2023 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 11/15/2019 | 53CD14EYELASH AND EYEBROW TREATMENTS-GEL, OIL, PRIMER, CONDITIONERS, SERUM, FORTIFIERS (EYE MAKEUP PREPARA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/11/2014 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | Chicago District Office (CHI-DO) | |
| 6/11/2014 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | Chicago District Office (CHI-DO) | |
| 6/11/2014 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | Chicago District Office (CHI-DO) | |
| 1/8/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Oceanic S.A.'s FDA import refusal history?
Oceanic S.A. (FEI: 3002886442) has 10 FDA import refusal record(s) in our database, spanning from 1/8/2013 to 2/15/2024.
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. Oceanic S.A.'s FEI number is 3002886442.
What types of violations has Oceanic S.A. received?
Oceanic S.A. has been cited for 6 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 Oceanic S.A. come from?
All FDA import refusal data for Oceanic S.A. 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.