SINOCHEM QINGDAO CO.,LTD.
⚠️ Moderate Risk
FEI: 3006446812 • Qingdao, Shandong • CHINA
FEI Number
3006446812
Location
Qingdao, Shandong
Country
CHINAAddress
20 Xianggangzhonglu, , Qingdao, Shandong, 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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
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.
ANDRO
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to declare and/or contain androstenedione, a new dietary 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.
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).
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/23/2010 | 24AGD13SOYBEANS (SEE INDUSTRY 37 FOR 'BEAN CURD') | 2920PESTICIDES | Seattle District Office (SEA-DO) |
| 10/7/2005 | 66PAS02AMINOBENZOIC ACID (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/18/2005 | 61JAY99ANTI-CHOLESTEREMIC, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/23/2005 | 54GBR04SHARK (ANIMAL BY-PRODUCTS AND EXTRACTS) | 249FILTHY | Division of West Coast Imports (DWCI) |
| 11/5/2004 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3100ANDRO | Florida District Office (FLA-DO) |
| 10/8/2004 | 62JDC09LEVODOPA (ANTI-PARKINSONIAN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/29/2004 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3100ANDRO | Cincinnati District Office (CIN-DO) |
| 9/14/2004 | 61GMS48SULFADIAZINE SODIUM (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/5/2004 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 12/8/2003 | 54CAR20L-TRYPTOPHAN (PROTEIN) | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 11/13/2003 | 54CEY20L-TRYPTOPHAN (PROTEIN) | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 9/5/2003 | 56DIS80TOBRAMYCIN SULFATE (AMINOGLYCOSIDES) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is SINOCHEM QINGDAO CO.,LTD.'s FDA import refusal history?
SINOCHEM QINGDAO CO.,LTD. (FEI: 3006446812) has 12 FDA import refusal record(s) in our database, spanning from 9/5/2003 to 8/23/2010.
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. SINOCHEM QINGDAO CO.,LTD.'s FEI number is 3006446812.
What types of violations has SINOCHEM QINGDAO CO.,LTD. received?
SINOCHEM QINGDAO CO.,LTD. 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 SINOCHEM QINGDAO CO.,LTD. come from?
All FDA import refusal data for SINOCHEM QINGDAO 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.