Bayer Healthcare, LLC
⚠️ Moderate Risk
FEI: 3000206585 • Morristown, NJ • UNITED STATES
FEI Number
3000206585
Location
Morristown, NJ
Country
UNITED STATESAddress
36 Columbia Rd, , Morristown, 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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/20/2020 | 61FDB54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 12/13/2019 | 64GDH19ETHINYL ESTRADIOL (ESTROGEN) | 179AGR RX | Division of Southeast Imports (DSEI) |
| 11/19/2018 | 60SAA07PRECIPITATED CALCIUM CARBONATE (ANTACID) | Division of Northern Border Imports (DNBI) | |
| 12/12/2007 | 64GCY29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/21/2005 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Bayer Healthcare, LLC's FDA import refusal history?
Bayer Healthcare, LLC (FEI: 3000206585) has 5 FDA import refusal record(s) in our database, spanning from 3/21/2005 to 7/20/2020.
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, LLC's FEI number is 3000206585.
What types of violations has Bayer Healthcare, LLC received?
Bayer Healthcare, LLC has been cited for 4 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, LLC come from?
All FDA import refusal data for Bayer Healthcare, LLC 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.