Guangzhou Pharmaceutical Import & Export Company Limited.
⚠️ Moderate Risk
FEI: 3004329161 • Guangzhou, Guangdong • CHINA
FEI Number
3004329161
Location
Guangzhou, Guangdong
Country
CHINAAddress
45 Shamien North Street, , Guangzhou, Guangdong, 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).
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.
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/25/2016 | 54FCA36BLACK COHOSH (HERBAL & BOTANICALS, NOT TEAS) | 324NO ENGLISH | San Francisco District Office (SAN-DO) |
| 9/2/2011 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 9/2/2011 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 1/6/2009 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/30/2008 | 66BAR99STIMULANT N.E.C. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 11/28/2006 | 30GCT99BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 4/28/2003 | 66VDE99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 4/30/2002 | 56GCJ99ANTIFUNGAL N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/29/2002 | 54FBL12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 2120UNSFDIETSP | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Guangzhou Pharmaceutical Import & Export Company Limited.'s FDA import refusal history?
Guangzhou Pharmaceutical Import & Export Company Limited. (FEI: 3004329161) has 9 FDA import refusal record(s) in our database, spanning from 1/29/2002 to 4/25/2016.
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. Guangzhou Pharmaceutical Import & Export Company Limited.'s FEI number is 3004329161.
What types of violations has Guangzhou Pharmaceutical Import & Export Company Limited. received?
Guangzhou Pharmaceutical Import & Export Company Limited. has been cited for 6 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 Guangzhou Pharmaceutical Import & Export Company Limited. come from?
All FDA import refusal data for Guangzhou Pharmaceutical Import & Export Company Limited. 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.