Nan San (HK) Pharmaceutical Factory Ltd.
⚠️ Moderate Risk
FEI: 3003723042 • Kwun Tong, Kowloon • HONG KONG
FEI Number
3003723042
Location
Kwun Tong, Kowloon
Country
HONG KONGAddress
6, Unit C, Hoi Bun Industrial Building Street; 1 Wing Yip Street, Kwun Tong, Kowloon, 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/1/2024 | 62MCY01CAMPHOR (ANTI-PRURITIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/29/2013 | 62MAL01CAMPHOR (ANTI-PRURITIC) | New York District Office (NYK-DO) | |
| 7/29/2013 | 62MAL01CAMPHOR (ANTI-PRURITIC) | New York District Office (NYK-DO) | |
| 7/29/2013 | 62MAL01CAMPHOR (ANTI-PRURITIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Nan San (HK) Pharmaceutical Factory Ltd.'s FDA import refusal history?
Nan San (HK) Pharmaceutical Factory Ltd. (FEI: 3003723042) has 4 FDA import refusal record(s) in our database, spanning from 7/29/2013 to 3/1/2024.
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. Nan San (HK) Pharmaceutical Factory Ltd.'s FEI number is 3003723042.
What types of violations has Nan San (HK) Pharmaceutical Factory Ltd. received?
Nan San (HK) Pharmaceutical Factory Ltd. has been cited for 3 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 Nan San (HK) Pharmaceutical Factory Ltd. come from?
All FDA import refusal data for Nan San (HK) Pharmaceutical Factory 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.