Nantong Jinghua Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3003735909 • Nantong, Jiangsu • CHINA
FEI Number
3003735909
Location
Nantong, Jiangsu
Country
CHINAAddress
Yanhai, No. 20 3 Haibin Road; Economic Development Zone, Nantong, Jiangsu, 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).
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.
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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 |
|---|---|---|---|
| 7/25/2017 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | Division of West Coast Imports (DWCI) | |
| 9/23/2014 | 62GCS59PIROXICAM (ANTI-INFLAMMATORY) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/17/2014 | 62QIR07PHENYLBUTAZONE (ANTI-RHEUMATIC) | New Orleans District Office (NOL-DO) | |
| 11/29/2013 | 62QCT07PHENYLBUTAZONE (ANTI-RHEUMATIC) | 16DIRECTIONS | Detroit District Office (DET-DO) |
| 9/18/2013 | 62QIZ07PHENYLBUTAZONE (ANTI-RHEUMATIC) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 5/8/2013 | 62QCY07PHENYLBUTAZONE (ANTI-RHEUMATIC) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 11/28/2012 | 62QCT07PHENYLBUTAZONE (ANTI-RHEUMATIC) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 9/2/2009 | 62QQR07PHENYLBUTAZONE (ANTI-RHEUMATIC) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 8/5/2009 | 62GCS99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 4/22/2008 | 62QCS07PHENYLBUTAZONE (ANTI-RHEUMATIC) | 16DIRECTIONS | Minneapolis District Office (MIN-DO) |
| 10/23/2003 | 62QRS07PHENYLBUTAZONE (ANTI-RHEUMATIC) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 10/21/2002 | 62GAS57PHENBUTAZONE SODIUM GLYCERATE (ANTI-INFLAMMATORY) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Nantong Jinghua Pharmaceutical Co., Ltd.'s FDA import refusal history?
Nantong Jinghua Pharmaceutical Co., Ltd. (FEI: 3003735909) has 12 FDA import refusal record(s) in our database, spanning from 10/21/2002 to 7/25/2017.
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. Nantong Jinghua Pharmaceutical Co., Ltd.'s FEI number is 3003735909.
What types of violations has Nantong Jinghua Pharmaceutical Co., Ltd. received?
Nantong Jinghua Pharmaceutical Co., Ltd. has been cited for 6 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 Nantong Jinghua Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Nantong Jinghua 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.