Tianjin Zhongan Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3003671775 • Tianjin, Tianjin • CHINA
FEI Number
3003671775
Location
Tianjin, Tianjin
Country
CHINAAddress
Xiqing, 188 Fukang Road, Tianjin, Tianjin, 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
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.
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).
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 |
|---|---|---|---|
| 2/24/2016 | 66BAS05CAFFEINE (STIMULANT) | 27DRUG GMPS | Chicago District Office (CHI-DO) |
| 2/24/2016 | 66BAS05CAFFEINE (STIMULANT) | 27DRUG GMPS | Chicago District Office (CHI-DO) |
| 10/13/2010 | 66BAZ05CAFFEINE (STIMULANT) | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/14/2008 | 62LAS40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/14/2007 | 62LCS40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 4/5/2005 | 62LCS40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Tianjin Zhongan Pharmaceutical Co., Ltd.'s FDA import refusal history?
Tianjin Zhongan Pharmaceutical Co., Ltd. (FEI: 3003671775) has 6 FDA import refusal record(s) in our database, spanning from 4/5/2005 to 2/24/2016.
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. Tianjin Zhongan Pharmaceutical Co., Ltd.'s FEI number is 3003671775.
What types of violations has Tianjin Zhongan Pharmaceutical Co., Ltd. received?
Tianjin Zhongan 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 Tianjin Zhongan Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Tianjin Zhongan 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.