Nanjing Baijingyu Pharmaceutical Co Ltd
⚠️ Moderate Risk
FEI: 3006037082 • Nanjing • CHINA
FEI Number
3006037082
Location
Nanjing
Country
CHINAAddress
No 1 Hanzhong Gate Ave, , Nanjing, , China
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 1/12/2012 | 54AEA90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 473LABELING | New Orleans District Office (NOL-DO) |
| 1/12/2012 | 56ECC22DOXYCYCLINE HYCLATE (TETRACYCLINES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/14/2008 | 56KCS10CHLORAMPHENICOL | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Nanjing Baijingyu Pharmaceutical Co Ltd's FDA import refusal history?
Nanjing Baijingyu Pharmaceutical Co Ltd (FEI: 3006037082) has 3 FDA import refusal record(s) in our database, spanning from 7/14/2008 to 1/12/2012.
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. Nanjing Baijingyu Pharmaceutical Co Ltd's FEI number is 3006037082.
What types of violations has Nanjing Baijingyu Pharmaceutical Co Ltd received?
Nanjing Baijingyu Pharmaceutical Co Ltd has been cited for 3 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 Nanjing Baijingyu Pharmaceutical Co Ltd come from?
All FDA import refusal data for Nanjing Baijingyu Pharmaceutical Co Ltd 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.