BEIJING GOLDENLASER DEVELOPMENT CO., LTD.
⚠️ Moderate Risk
FEI: 3009078366 • Langfang, Hebei • CHINA
FEI Number
3009078366
Location
Langfang, Hebei
Country
CHINAAddress
1st Floor # 339, Shenwei North Rd; Yanjiaozhen Sanhe, Langfang, Hebei, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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 |
|---|---|---|---|
| 6/30/2017 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Northern Border Imports (DNBI) | |
| 5/12/2017 | 79OYWFOR THE REMOVAL OF FAT THROUGH LASER LIPOLYSIS | Division of Southeast Imports (DSEI) | |
| 2/18/2014 | 76LYBLASER, DENTAL | Cincinnati District Office (CIN-DO) | |
| 9/8/2011 | 89ILXDIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is BEIJING GOLDENLASER DEVELOPMENT CO., LTD.'s FDA import refusal history?
BEIJING GOLDENLASER DEVELOPMENT CO., LTD. (FEI: 3009078366) has 4 FDA import refusal record(s) in our database, spanning from 9/8/2011 to 6/30/2017.
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. BEIJING GOLDENLASER DEVELOPMENT CO., LTD.'s FEI number is 3009078366.
What types of violations has BEIJING GOLDENLASER DEVELOPMENT CO., LTD. received?
BEIJING GOLDENLASER DEVELOPMENT CO., LTD. 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 BEIJING GOLDENLASER DEVELOPMENT CO., LTD. come from?
All FDA import refusal data for BEIJING GOLDENLASER DEVELOPMENT 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.