Shandong Lukang Shelile Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3001040579 • Jining, Shandong • CHINA
FEI Number
3001040579
Location
Jining, Shandong
Country
CHINAAddress
Hualu Road, Zoucheng Industrial Park 50, , Jining, 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 3/16/2015 | 56LXS99NON-CERT VET ANTIBIOTIC, N.E.C. | 72NEW VET DR | Detroit District Office (DET-DO) |
| 3/16/2015 | 56LXS99NON-CERT VET ANTIBIOTIC, N.E.C. | 72NEW VET DR | Detroit District Office (DET-DO) |
| 3/16/2015 | 56LXS99NON-CERT VET ANTIBIOTIC, N.E.C. | 72NEW VET DR | Detroit District Office (DET-DO) |
| 2/19/2015 | 56LXS99NON-CERT VET ANTIBIOTIC, N.E.C. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 5/8/2013 | 56LCY72TYLOSIN TARTRATE (NON-CERTIFIABLE) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 5/8/2013 | 56LCY72TYLOSIN TARTRATE (NON-CERTIFIABLE) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 11/6/2012 | 56LXS72TYLOSIN TARTRATE (NON-CERTIFIABLE) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shandong Lukang Shelile Pharmaceutical Co., Ltd.'s FDA import refusal history?
Shandong Lukang Shelile Pharmaceutical Co., Ltd. (FEI: 3001040579) has 7 FDA import refusal record(s) in our database, spanning from 11/6/2012 to 3/16/2015.
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. Shandong Lukang Shelile Pharmaceutical Co., Ltd.'s FEI number is 3001040579.
What types of violations has Shandong Lukang Shelile Pharmaceutical Co., Ltd. received?
Shandong Lukang Shelile Pharmaceutical Co., Ltd. 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 Shandong Lukang Shelile Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Shandong Lukang Shelile 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.