Reyoung Pharmaceutical Company, Ltd.
⚠️ Moderate Risk
FEI: 3003849441 • Zibo, Shandong • CHINA
FEI Number
3003849441
Location
Zibo, Shandong
Country
CHINAAddress
1 Ruiyang Avenue, Yiyuanxian, Zibo, Shandong, 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
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).
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 |
|---|---|---|---|
| 4/21/2023 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/6/2020 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/21/2016 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/13/2016 | 54AEP05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/5/2015 | 56CCA11CEFAZOLIN SODIUM (CEPHALOSPORINS) | Florida District Office (FLA-DO) | |
| 11/5/2015 | 56BAK55OXACILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | Florida District Office (FLA-DO) | |
| 11/5/2015 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Florida District Office (FLA-DO) | |
| 6/2/2010 | 61TBH12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Reyoung Pharmaceutical Company, Ltd.'s FDA import refusal history?
Reyoung Pharmaceutical Company, Ltd. (FEI: 3003849441) has 8 FDA import refusal record(s) in our database, spanning from 6/2/2010 to 4/21/2023.
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. Reyoung Pharmaceutical Company, Ltd.'s FEI number is 3003849441.
What types of violations has Reyoung Pharmaceutical Company, Ltd. received?
Reyoung Pharmaceutical Company, 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 Reyoung Pharmaceutical Company, Ltd. come from?
All FDA import refusal data for Reyoung Pharmaceutical Company, 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.