Henan Lihua Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3001164052 • Anyang, Henan • CHINA
FEI Number
3001164052
Location
Anyang, Henan
Country
CHINAAddress
Middle Of Huanghe Street, Anyang Hi-Tech Industry Development Zone, Anyang, Henan, 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.
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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 |
|---|---|---|---|
| 2/19/2021 | 60YOY99INHIBITOR (GROWTH FACTOR) N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/24/2017 | 64LAS50PREDNISOLONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 6/27/2016 | 64LDY37HYDROCORTISONE (GLUCOCORTICOID) | Cincinnati District Office (CIN-DO) | |
| 4/7/2016 | 64LCY38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/4/2014 | 64LCR41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 6/3/2013 | 64LQY37HYDROCORTISONE (GLUCOCORTICOID) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 4/20/2007 | 64LCS56PREDNISONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/13/2002 | 64LIY50PREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Henan Lihua Pharmaceutical Co., Ltd.'s FDA import refusal history?
Henan Lihua Pharmaceutical Co., Ltd. (FEI: 3001164052) has 8 FDA import refusal record(s) in our database, spanning from 4/13/2002 to 2/19/2021.
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. Henan Lihua Pharmaceutical Co., Ltd.'s FEI number is 3001164052.
What types of violations has Henan Lihua Pharmaceutical Co., Ltd. received?
Henan Lihua Pharmaceutical Co., Ltd. has been cited for 5 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 Henan Lihua Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Henan Lihua 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.