Teamedics Manufacturing
⚠️ Moderate Risk
FEI: 3003156969 • Xin An Town Bao An Country Shenzhen • CHINA
FEI Number
3003156969
Location
Xin An Town Bao An Country Shenzhen
Country
CHINAAddress
Block 6/13, He Dong Industrial Village, , Xin An Town Bao An Country Shenzhen, , 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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
Frequently Asked Questions
What is Teamedics Manufacturing's FDA import refusal history?
Teamedics Manufacturing (FEI: 3003156969) has 3 FDA import refusal record(s) in our database, spanning from 4/4/2007 to 11/15/2007.
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. Teamedics Manufacturing's FEI number is 3003156969.
What types of violations has Teamedics Manufacturing received?
Teamedics Manufacturing has been cited for 2 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 Teamedics Manufacturing come from?
All FDA import refusal data for Teamedics Manufacturing 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.