Guangzhou Tinci Materials Technology Co., Ltd.
⚠️ Moderate Risk
FEI: 3007544618 • Guangzhou, Guangdong • CHINA
FEI Number
3007544618
Location
Guangzhou, Guangdong
Country
CHINAAddress
Yunpu Industrial Zone, 8th Kangda Road; Huangpu District, Guangzhou, Guangdong, 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).
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).
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).
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.
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.
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/16/2023 | 55RY99PHARMACEUTIC NECESSITIES, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/14/2023 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/10/2016 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Cincinnati District Office (CIN-DO) | |
| 6/21/2012 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | Los Angeles District Office (LOS-DO) | |
| 3/28/2012 | 89EGJDEVICE, IONTOPHORESIS, OTHER USES | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Guangzhou Tinci Materials Technology Co., Ltd.'s FDA import refusal history?
Guangzhou Tinci Materials Technology Co., Ltd. (FEI: 3007544618) has 5 FDA import refusal record(s) in our database, spanning from 3/28/2012 to 8/16/2023.
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. Guangzhou Tinci Materials Technology Co., Ltd.'s FEI number is 3007544618.
What types of violations has Guangzhou Tinci Materials Technology Co., Ltd. received?
Guangzhou Tinci Materials Technology Co., Ltd. has been cited for 9 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 Guangzhou Tinci Materials Technology Co., Ltd. come from?
All FDA import refusal data for Guangzhou Tinci Materials Technology 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.