GUANGDONG KEMEI PHARMACEUTICAL TECHNOLOGY CO LTD
⚠️ Moderate Risk
FEI: 3017086967 • Foshan, Guangdong • CHINA
FEI Number
3017086967
Location
Foshan, Guangdong
Country
CHINAAddress
3rd And 4th Floor, No 16 (#6 Plant) Jiye Rd, Nanhai, Foshan, Guangdong, 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).
TAMPERING
It appears that the packing does not conform with current good manufacturing practices under 21 CFR 211.132 for tamper-resistant packaging.
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 |
|---|---|---|---|
| 2/26/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of West Coast Imports (DWCI) | |
| 2/26/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of West Coast Imports (DWCI) | |
| 2/26/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of West Coast Imports (DWCI) | |
| 2/26/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of West Coast Imports (DWCI) | |
| 2/26/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is GUANGDONG KEMEI PHARMACEUTICAL TECHNOLOGY CO LTD's FDA import refusal history?
GUANGDONG KEMEI PHARMACEUTICAL TECHNOLOGY CO LTD (FEI: 3017086967) has 5 FDA import refusal record(s) in our database, spanning from 2/26/2021 to 2/26/2021.
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. GUANGDONG KEMEI PHARMACEUTICAL TECHNOLOGY CO LTD's FEI number is 3017086967.
What types of violations has GUANGDONG KEMEI PHARMACEUTICAL TECHNOLOGY CO LTD received?
GUANGDONG KEMEI PHARMACEUTICAL TECHNOLOGY 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 GUANGDONG KEMEI PHARMACEUTICAL TECHNOLOGY CO LTD come from?
All FDA import refusal data for GUANGDONG KEMEI PHARMACEUTICAL TECHNOLOGY 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.