Bayer Healthcare Pharmaceuticals Inc.
⚠️ Moderate Risk
FEI: 2243252 • Whippany, NJ • UNITED STATES
FEI Number
2243252
Location
Whippany, NJ
Country
UNITED STATESAddress
100 Bayer Blvd, , Whippany, NJ, United States
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/3/2022 | 60CRQ48OXYMETAZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/7/2021 | 85HHSTRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | Division of West Coast Imports (DWCI) | |
| 6/19/2020 | 60LAA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/16/2019 | 65JDA99PROGESTIN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/10/2017 | 74DQFACTUATOR, SYRINGE, INJECTOR TYPE | Division of Northern Border Imports (DNBI) | |
| 5/30/2012 | 65JDA39DROSPIRENONE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/23/2009 | 64GCY29LEVONORGESTREL (ESTROGEN) | Cincinnati District Office (CIN-DO) | |
| 11/5/2009 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/30/2008 | 66VDK99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Bayer Healthcare Pharmaceuticals Inc.'s FDA import refusal history?
Bayer Healthcare Pharmaceuticals Inc. (FEI: 2243252) has 9 FDA import refusal record(s) in our database, spanning from 4/30/2008 to 1/3/2022.
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 Healthcare Pharmaceuticals Inc.'s FEI number is 2243252.
What types of violations has Bayer Healthcare Pharmaceuticals Inc. received?
Bayer Healthcare Pharmaceuticals Inc. 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 Bayer Healthcare Pharmaceuticals Inc. come from?
All FDA import refusal data for Bayer Healthcare 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.