GUANGZHOU BACELA IMPORT EXPORT CO LIMITED

⚠️ Moderate Risk

FEI: 3016917587 • Guangzhou • CHINA

FEI

FEI Number

3016917587

📍

Location

Guangzhou

🇨🇳

Country

CHINA

🏢

Address

Gaosheng Plaza Room 10 Floor 13a, , Guangzhou, , China

Moderate Risk

FDA Import Risk Assessment

47.1

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

11/9/2021

Latest Refusal

11/9/2021

Earliest Refusal

Score Breakdown

Violation Severity

70.0×40%

Refusal Volume

35.3×30%

Recency

2.3×20%

Frequency

80.0×10%

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

Violation Summary

1188×

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).

758×

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
11/9/2021	66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of Southeast Imports (DSEI)
11/9/2021	66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of Southeast Imports (DSEI)
11/9/2021	66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of Southeast Imports (DSEI)
11/9/2021	66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of Southeast Imports (DSEI)
11/9/2021	66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of Southeast Imports (DSEI)
11/9/2021	66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of Southeast Imports (DSEI)
11/9/2021	66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of Southeast Imports (DSEI)
11/9/2021	66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GUANGZHOU BACELA IMPORT EXPORT CO LIMITED's FDA import refusal history?

GUANGZHOU BACELA IMPORT EXPORT CO LIMITED (FEI: 3016917587) has 8 FDA import refusal record(s) in our database, spanning from 11/9/2021 to 11/9/2021.

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. GUANGZHOU BACELA IMPORT EXPORT CO LIMITED's FEI number is 3016917587.

What types of violations has GUANGZHOU BACELA IMPORT EXPORT CO LIMITED received?

GUANGZHOU BACELA IMPORT EXPORT CO LIMITED has been cited for 2 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 BACELA IMPORT EXPORT CO LIMITED come from?

All FDA import refusal data for GUANGZHOU BACELA IMPORT EXPORT CO LIMITED 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.