Chemycos Technologies Co Ltd.
⚠️ Moderate Risk
FEI: 3003626603 • Shanghai, Shanghai • CHINA
FEI Number
3003626603
Location
Shanghai, Shanghai
Country
CHINAAddress
Block Lin 7 Room 201NO, 265 Kangle Huayuan, Shanghai, Shanghai, 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).
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 |
|---|---|---|---|
| 5/29/2002 | 61FDS33ERTHROMYCIN ETHYLCARBONATE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Los Angeles District Office (LOS-DO) | |
| 4/29/2002 | 61FDS33ERTHROMYCIN ETHYLCARBONATE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Chemycos Technologies Co Ltd.'s FDA import refusal history?
Chemycos Technologies Co Ltd. (FEI: 3003626603) has 2 FDA import refusal record(s) in our database, spanning from 4/29/2002 to 5/29/2002.
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. Chemycos Technologies Co Ltd.'s FEI number is 3003626603.
What types of violations has Chemycos Technologies Co Ltd. received?
Chemycos Technologies Co Ltd. has been cited for 2 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 Chemycos Technologies Co Ltd. come from?
All FDA import refusal data for Chemycos Technologies 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.