Sage Pharmaceuticals Inc.
⚠️ High Risk
FEI: 3014247166 • New Taipei City • TAIWAN
FEI Number
3014247166
Location
New Taipei City
Country
TAIWANAddress
4 F, No. 1 Wugong 5th Rd.; Xinzhuang Dist., New Taipei City, , Taiwan
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
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 |
|---|---|---|---|
| 8/15/2024 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 1/25/2022 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/25/2022 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/6/2021 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 12/6/2021 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 12/6/2021 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/6/2021 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/6/2021 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/6/2021 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/6/2021 | 53CC05EYE MAKEUP REMOVER (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/6/2021 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/6/2021 | 53CD04EYE LOTION (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/6/2021 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/6/2021 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/6/2021 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/6/2021 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/6/2021 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/6/2021 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Sage Pharmaceuticals Inc.'s FDA import refusal history?
Sage Pharmaceuticals Inc. (FEI: 3014247166) has 18 FDA import refusal record(s) in our database, spanning from 12/6/2021 to 8/15/2024.
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. Sage Pharmaceuticals Inc.'s FEI number is 3014247166.
What types of violations has Sage Pharmaceuticals Inc. received?
Sage Pharmaceuticals Inc. has been cited for 2 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 Sage Pharmaceuticals Inc. come from?
All FDA import refusal data for Sage Pharmaceuticals 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.