Firstar Health Care Company
⚠️ Moderate Risk
FEI: 3005800001 • Zhujinag New Cityzhujinag New City • CHINA
FEI Number
3005800001
Location
Zhujinag New Cityzhujinag New City
Country
CHINAAddress
Rm 1003 E Towerhuapu Office Complex No, , Zhujinag New Cityzhujinag New City, , 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).
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.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/8/2012 | 73LYMDEVICE, CPR ASSIST | New York District Office (NYK-DO) | |
| 8/8/2012 | 73LYMDEVICE, CPR ASSIST | New York District Office (NYK-DO) | |
| 8/8/2012 | 73LYMDEVICE, CPR ASSIST | New York District Office (NYK-DO) | |
| 8/8/2012 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | New York District Office (NYK-DO) |
| 10/24/2011 | 73BYGMASK, OXYGEN | 473LABELING | Los Angeles District Office (LOS-DO) |
| 10/24/2011 | 73BYGMASK, OXYGEN | 473LABELING | Los Angeles District Office (LOS-DO) |
| 3/2/2011 | 73BYGMASK, OXYGEN | Los Angeles District Office (LOS-DO) | |
| 3/2/2011 | 73BYGMASK, OXYGEN | Los Angeles District Office (LOS-DO) | |
| 3/2/2011 | 73BYGMASK, OXYGEN | Los Angeles District Office (LOS-DO) | |
| 3/2/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Los Angeles District Office (LOS-DO) | |
| 3/2/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Los Angeles District Office (LOS-DO) | |
| 3/2/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Los Angeles District Office (LOS-DO) | |
| 3/2/2011 | 73BYGMASK, OXYGEN | Los Angeles District Office (LOS-DO) | |
| 3/2/2011 | 73BYGMASK, OXYGEN | Los Angeles District Office (LOS-DO) | |
| 3/2/2011 | 73BYGMASK, OXYGEN | Los Angeles District Office (LOS-DO) | |
| 3/2/2011 | 73BYGMASK, OXYGEN | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Firstar Health Care Company's FDA import refusal history?
Firstar Health Care Company (FEI: 3005800001) has 16 FDA import refusal record(s) in our database, spanning from 3/2/2011 to 8/8/2012.
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. Firstar Health Care Company's FEI number is 3005800001.
What types of violations has Firstar Health Care Company received?
Firstar Health Care Company has been cited for 8 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 Firstar Health Care Company come from?
All FDA import refusal data for Firstar Health Care Company 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.