GFA Production Xiamen Co., Ltd.
⚠️ Moderate Risk
FEI: 3008384335 • Xiamen, Fujian • CHINA
FEI Number
3008384335
Location
Xiamen, Fujian
Country
CHINAAddress
Huli Industrial Park No. 20, Meixi Street; Tongan, Xiamen, Fujian, 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).
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/10/2025 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | Division of Southwest Imports (DSWI) | |
| 10/24/2022 | 60LBY99ANALGESIC, N.E.C. | 336INCONSPICU | Division of Southwest Imports (DSWI) |
| 10/24/2022 | 60LBY99ANALGESIC, N.E.C. | 336INCONSPICU | Division of Southwest Imports (DSWI) |
| 1/6/2021 | 55QY41BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 9/22/2011 | 60LAS05ASPIRIN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/22/2011 | 60LAQ01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/22/2011 | 61XAA18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/22/2011 | 62GBZ41IBUPROFEN (ANTI-INFLAMMATORY) | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/22/2011 | 60LAQ01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/8/2010 | 65FBK06WATER, PURIFIED (EYEWASH) | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 9/7/2010 | 73BYPMOUTHPIECE, BREATHING | Los Angeles District Office (LOS-DO) | |
| 9/7/2010 | 73BYPMOUTHPIECE, BREATHING | Los Angeles District Office (LOS-DO) | |
| 9/7/2010 | 73BYPMOUTHPIECE, BREATHING | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is GFA Production Xiamen Co., Ltd.'s FDA import refusal history?
GFA Production Xiamen Co., Ltd. (FEI: 3008384335) has 13 FDA import refusal record(s) in our database, spanning from 9/7/2010 to 1/10/2025.
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. GFA Production Xiamen Co., Ltd.'s FEI number is 3008384335.
What types of violations has GFA Production Xiamen Co., Ltd. received?
GFA Production Xiamen 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 GFA Production Xiamen Co., Ltd. come from?
All FDA import refusal data for GFA Production Xiamen 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.