Guangzhou Haishi Biological Technology Co., Ltd.
⚠️ High Risk
FEI: 3010166847 • Guangzhou, Guangdong • CHINA
FEI Number
3010166847
Location
Guangzhou, Guangdong
Country
CHINAAddress
1st Floor 2nd Floor, No. 10 Xiamao Songyuan Road, Baiyun Lake Street; Baiyun, Guangzhou, Guangdong, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/17/2025 | 66PBR18ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 10/21/2025 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/21/2025 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/19/2025 | 60QAJ67LIDOCAINE (ANESTHETIC) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 12/15/2023 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 12/5/2023 | 66PAL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 7/31/2023 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/6/2023 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/5/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of West Coast Imports (DWCI) | |
| 1/5/2021 | 80LRJDISINFECTANT, MEDICAL DEVICES | Division of West Coast Imports (DWCI) | |
| 8/21/2020 | 62HAC05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 5/5/2020 | 64ABO99DISINFECTANT N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 5/20/2016 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
| 5/20/2016 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Guangzhou Haishi Biological Technology Co., Ltd.'s FDA import refusal history?
Guangzhou Haishi Biological Technology Co., Ltd. (FEI: 3010166847) has 14 FDA import refusal record(s) in our database, spanning from 5/20/2016 to 11/17/2025.
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. Guangzhou Haishi Biological Technology Co., Ltd.'s FEI number is 3010166847.
What types of violations has Guangzhou Haishi Biological Technology Co., Ltd. received?
Guangzhou Haishi Biological Technology Co., Ltd. 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 Guangzhou Haishi Biological Technology Co., Ltd. come from?
All FDA import refusal data for Guangzhou Haishi Biological 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.