Peking Medicine Manufactory
⚠️ Moderate Risk
FEI: 3004186759 • Tsuen Wan, New Territories • HONG KONG
FEI Number
3004186759
Location
Tsuen Wan, New Territories
Country
HONG KONGAddress
Unit B, 7/F, Phase 1, Leader Industry Centre, Tsuen Wan, New Territories, 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).
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/3/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 6/6/2005 | 80FQMBANDAGE, ELASTIC | Seattle District Office (SEA-DO) | |
| 5/24/2005 | 54FBH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 11/8/2004 | 66VBE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 11/8/2004 | 66VBE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 11/8/2004 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 12/31/2003 | 54FBE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Peking Medicine Manufactory's FDA import refusal history?
Peking Medicine Manufactory (FEI: 3004186759) has 7 FDA import refusal record(s) in our database, spanning from 12/31/2003 to 1/3/2006.
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. Peking Medicine Manufactory's FEI number is 3004186759.
What types of violations has Peking Medicine Manufactory received?
Peking Medicine Manufactory has been cited for 8 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 Peking Medicine Manufactory come from?
All FDA import refusal data for Peking Medicine Manufactory 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.