Suzhou Lixin Pharmaceutical Co. Ltd.
⚠️ Moderate Risk
FEI: 3008251350 • Suzhou, Jiangsu • CHINA
FEI Number
3008251350
Location
Suzhou, Jiangsu
Country
CHINAAddress
21 Tangxi Road, , Suzhou, Jiangsu, 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
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.
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.
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/10/2021 | 53YH99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 9/26/2016 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/15/2016 | 54YYR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/12/2015 | 54YYS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/18/2014 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 6/11/2014 | 66VCR99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 7/6/2011 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 1/25/2011 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2200DIET INGRE | Los Angeles District Office (LOS-DO) |
| 1/25/2011 | 54YBS08COENZYME Q10 (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 2200DIET INGRE | Los Angeles District Office (LOS-DO) |
| 11/15/2010 | 66BIY99STIMULANT N.E.C. | Cincinnati District Office (CIN-DO) | |
| 6/3/2005 | 66VCR99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 3/16/2005 | 64BCZ25HYDROCHLOROTHIAZIDE (DIURETIC) | Los Angeles District Office (LOS-DO) | |
| 1/12/2005 | 66VAS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Suzhou Lixin Pharmaceutical Co. Ltd.'s FDA import refusal history?
Suzhou Lixin Pharmaceutical Co. Ltd. (FEI: 3008251350) has 13 FDA import refusal record(s) in our database, spanning from 1/12/2005 to 2/10/2021.
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. Suzhou Lixin Pharmaceutical Co. Ltd.'s FEI number is 3008251350.
What types of violations has Suzhou Lixin Pharmaceutical Co. Ltd. received?
Suzhou Lixin 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 Suzhou Lixin Pharmaceutical Co. Ltd. come from?
All FDA import refusal data for Suzhou Lixin 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.