Luotian Xinpusheng Pharmaceutical Co.,Ltd.
⚠️ Moderate Risk
FEI: 3009929149 • Huanggang, Hubei • CHINA
FEI Number
3009929149
Location
Huanggang, Hubei
Country
CHINAAddress
No. 152 Luotian Guangchang, Luotianxian, Huanggang, Hubei, 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
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.
DIET INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 11/17/2015 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | San Francisco District Office (SAN-DO) | |
| 10/15/2012 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Luotian Xinpusheng Pharmaceutical Co.,Ltd.'s FDA import refusal history?
Luotian Xinpusheng Pharmaceutical Co.,Ltd. (FEI: 3009929149) has 2 FDA import refusal record(s) in our database, spanning from 10/15/2012 to 11/17/2015.
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. Luotian Xinpusheng Pharmaceutical Co.,Ltd.'s FEI number is 3009929149.
What types of violations has Luotian Xinpusheng Pharmaceutical Co.,Ltd. received?
Luotian Xinpusheng Pharmaceutical Co.,Ltd. has been cited for 5 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 Luotian Xinpusheng Pharmaceutical Co.,Ltd. come from?
All FDA import refusal data for Luotian Xinpusheng Pharmaceutical 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.