Cheong Chun Tong Medical Manufactory Inc.
⚠️ Moderate Risk
FEI: 3004200715 • Chai Wan • HONG KONG
FEI Number
3004200715
Location
Chai Wan
Country
HONG KONGAddress
Flat/Room C, 7/F Sunview Industrial, Bldg., 3 On Yip Street, Chai Wan, , Hong Kong
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).
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
TAMPERING
It appears that the packing does not conform with current good manufacturing practices under 21 CFR 211.132 for tamper-resistant packaging.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/25/2007 | 60LAJ63SALICYLAMIDE (ANALGESIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/25/2007 | 60LAJ63SALICYLAMIDE (ANALGESIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/8/2006 | 60LAJ63SALICYLAMIDE (ANALGESIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/7/2005 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/20/2005 | 60LAJ63SALICYLAMIDE (ANALGESIC) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Cheong Chun Tong Medical Manufactory Inc.'s FDA import refusal history?
Cheong Chun Tong Medical Manufactory Inc. (FEI: 3004200715) has 5 FDA import refusal record(s) in our database, spanning from 4/20/2005 to 5/25/2007.
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. Cheong Chun Tong Medical Manufactory Inc.'s FEI number is 3004200715.
What types of violations has Cheong Chun Tong Medical Manufactory Inc. received?
Cheong Chun Tong Medical Manufactory Inc. 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 Cheong Chun Tong Medical Manufactory Inc. come from?
All FDA import refusal data for Cheong Chun Tong Medical Manufactory Inc. 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.