Tianjin Central Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3003780972 • Tianjin, Tianjin • CHINA
FEI Number
3003780972
Location
Tianjin, Tianjin
Country
CHINAAddress
No. 1 Fujin Road, Beichen, 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
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/8/2008 | 54YCK10ROYAL JELLY (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | Los Angeles District Office (LOS-DO) | |
| 5/8/2008 | 54FBK12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | Los Angeles District Office (LOS-DO) | |
| 5/8/2008 | 54FBK12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | Los Angeles District Office (LOS-DO) | |
| 6/3/2003 | 60NAS14TESTOSTERONE (ANDROGEN) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Tianjin Central Pharmaceutical Co., Ltd.'s FDA import refusal history?
Tianjin Central Pharmaceutical Co., Ltd. (FEI: 3003780972) has 4 FDA import refusal record(s) in our database, spanning from 6/3/2003 to 5/8/2008.
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 Central Pharmaceutical Co., Ltd.'s FEI number is 3003780972.
What types of violations has Tianjin Central Pharmaceutical Co., Ltd. received?
Tianjin Central 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 Central Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Tianjin Central 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.