Yinjing Medical Technology (Shanghai) Co., Ltd.
⚠️ Moderate Risk
FEI: 3005731037 • Shanghai • CHINA
FEI Number
3005731037
Location
Shanghai
Country
CHINAAddress
Nanhui Industry Park, No. 586 Yuanxilu; Nanhui, Shanghai, , 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
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).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 |
|---|---|---|---|
| 4/24/2018 | 62FAY20IODINE (ANTI-INFECTIVE, TOPICAL) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 4/24/2018 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 4/24/2018 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/13/2018 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 9/20/2016 | 62FAK99ANTI-INFECTIVE, TOPICAL N.E.C. | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 9/20/2016 | 62FAK99ANTI-INFECTIVE, TOPICAL N.E.C. | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 9/20/2016 | 62FAK99ANTI-INFECTIVE, TOPICAL N.E.C. | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 9/20/2016 | 62FAK99ANTI-INFECTIVE, TOPICAL N.E.C. | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 9/20/2016 | 62FAK23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 9/20/2016 | 62FAK99ANTI-INFECTIVE, TOPICAL N.E.C. | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 5/18/2016 | 62FAK99ANTI-INFECTIVE, TOPICAL N.E.C. | Division of Northern Border Imports (DNBI) | |
| 5/18/2016 | 62FAK99ANTI-INFECTIVE, TOPICAL N.E.C. | Division of Northern Border Imports (DNBI) | |
| 9/24/2014 | 53LF01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/24/2014 | 53LF01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/17/2012 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | San Francisco District Office (SAN-DO) |
| 8/17/2012 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | San Francisco District Office (SAN-DO) |
| 8/17/2012 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | San Francisco District Office (SAN-DO) |
| 8/17/2012 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | San Francisco District Office (SAN-DO) |
| 8/17/2012 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | San Francisco District Office (SAN-DO) |
| 3/14/2012 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | San Francisco District Office (SAN-DO) |
| 3/14/2012 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | San Francisco District Office (SAN-DO) |
| 3/7/2012 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Yinjing Medical Technology (Shanghai) Co., Ltd.'s FDA import refusal history?
Yinjing Medical Technology (Shanghai) Co., Ltd. (FEI: 3005731037) has 22 FDA import refusal record(s) in our database, spanning from 3/7/2012 to 4/24/2018.
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. Yinjing Medical Technology (Shanghai) Co., Ltd.'s FEI number is 3005731037.
What types of violations has Yinjing Medical Technology (Shanghai) Co., Ltd. received?
Yinjing Medical Technology (Shanghai) Co., Ltd. has been cited for 4 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 Yinjing Medical Technology (Shanghai) Co., Ltd. come from?
All FDA import refusal data for Yinjing Medical Technology (Shanghai) 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.