Bayer corporation consumer care.
⚠️ Moderate Risk
FEI: 3010380233 • Guatemala, Guatemala • GUATEMALA
FEI Number
3010380233
Location
Guatemala, Guatemala
Country
GUATEMALAAddress
Calzada Roosevelt ,mixco, , Guatemala, Guatemala, Guatemala
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
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 |
|---|---|---|---|
| 1/19/2021 | 63ADY02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/8/2020 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/18/2014 | 65RBY18SODIUM BICARBONATE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Bayer corporation consumer care.'s FDA import refusal history?
Bayer corporation consumer care. (FEI: 3010380233) has 3 FDA import refusal record(s) in our database, spanning from 4/18/2014 to 1/19/2021.
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. Bayer corporation consumer care.'s FEI number is 3010380233.
What types of violations has Bayer corporation consumer care. received?
Bayer corporation consumer care. has been cited for 1 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 Bayer corporation consumer care. come from?
All FDA import refusal data for Bayer corporation consumer care. 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.