Allmed Medical Products Co Ltd. (Shenzen Factory)
⚠️ High Risk
FEI: 3005552103 • Shenzen • CHINA
FEI Number
3005552103
Location
Shenzen
Country
CHINAAddress
Room 1911, Hanggang Fuchun Business BLDG, 6031th Shennan Middle Road, Shenzen, , China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
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.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/25/2013 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | San Francisco District Office (SAN-DO) |
| 6/25/2013 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | San Francisco District Office (SAN-DO) |
| 5/24/2013 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | Chicago District Office (CHI-DO) | |
| 5/13/2013 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | Detroit District Office (DET-DO) |
| 5/13/2013 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | Detroit District Office (DET-DO) |
| 5/13/2013 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | Detroit District Office (DET-DO) |
| 5/13/2013 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | Detroit District Office (DET-DO) |
| 5/13/2013 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | Detroit District Office (DET-DO) |
| 5/13/2013 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | Detroit District Office (DET-DO) |
| 3/25/2013 | 79GDYGAUZE, NONABSORABLE, X-RAY DETECTABLE (INTERNAL SPONGE) | 78STERILITY | New York District Office (NYK-DO) |
| 3/25/2013 | 79GDYGAUZE, NONABSORABLE, X-RAY DETECTABLE (INTERNAL SPONGE) | 78STERILITY | New York District Office (NYK-DO) |
| 2/20/2013 | 79EFQSPONGE, GAUZE | Florida District Office (FLA-DO) | |
| 2/20/2013 | 79EFQSPONGE, GAUZE | Florida District Office (FLA-DO) | |
| 2/20/2013 | 79EFQSPONGE, GAUZE | Florida District Office (FLA-DO) | |
| 2/20/2013 | 79EFQSPONGE, GAUZE | Florida District Office (FLA-DO) | |
| 2/20/2013 | 79EFQSPONGE, GAUZE | Florida District Office (FLA-DO) | |
| 2/20/2013 | 79GDYGAUZE, NONABSORABLE, X-RAY DETECTABLE (INTERNAL SPONGE) | Florida District Office (FLA-DO) | |
| 2/20/2013 | 79EFQSPONGE, GAUZE | Florida District Office (FLA-DO) | |
| 2/20/2013 | 79GDYGAUZE, NONABSORABLE, X-RAY DETECTABLE (INTERNAL SPONGE) | Florida District Office (FLA-DO) | |
| 2/12/2013 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Allmed Medical Products Co Ltd. (Shenzen Factory)'s FDA import refusal history?
Allmed Medical Products Co Ltd. (Shenzen Factory) (FEI: 3005552103) has 20 FDA import refusal record(s) in our database, spanning from 2/12/2013 to 6/25/2013.
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. Allmed Medical Products Co Ltd. (Shenzen Factory)'s FEI number is 3005552103.
What types of violations has Allmed Medical Products Co Ltd. (Shenzen Factory) received?
Allmed Medical Products Co Ltd. (Shenzen Factory) 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 Allmed Medical Products Co Ltd. (Shenzen Factory) come from?
All FDA import refusal data for Allmed Medical Products Co Ltd. (Shenzen Factory) 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.