Pyunghwa Industrial Co. - Hula Hoop Mfg.
⚠️ Moderate Risk
FEI: 3006993664 • Unknown • SOUTH KOREA
FEI Number
3006993664
Location
Unknown
Country
SOUTH KOREAAddress
Unknown St, , Unknown, , South Korea
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/5/2009 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/5/2009 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/17/2008 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 10/17/2008 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Pyunghwa Industrial Co. - Hula Hoop Mfg.'s FDA import refusal history?
Pyunghwa Industrial Co. - Hula Hoop Mfg. (FEI: 3006993664) has 4 FDA import refusal record(s) in our database, spanning from 10/17/2008 to 11/5/2009.
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. Pyunghwa Industrial Co. - Hula Hoop Mfg.'s FEI number is 3006993664.
What types of violations has Pyunghwa Industrial Co. - Hula Hoop Mfg. received?
Pyunghwa Industrial Co. - Hula Hoop Mfg. has been cited for 3 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 Pyunghwa Industrial Co. - Hula Hoop Mfg. come from?
All FDA import refusal data for Pyunghwa Industrial Co. - Hula Hoop Mfg. 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.