Zhengtangzhuang Xiamen Healthcare Co., Ltd.

⚠️ Moderate Risk

FEI: 3008438088 • Fujian • CHINA

FEI

FEI Number

3008438088

📍

Location

Fujian

🇨🇳

Country

CHINA

🏢

Address

400 Building 25 Huli Industrial Park, , Fujian, , China

Moderate Risk

FDA Import Risk Assessment

35.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

1/18/2011

Latest Refusal

1/18/2011

Earliest Refusal

Score Breakdown

Violation Severity

51.1×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

60.0×10%

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

2626×

DIETARY

The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.

4826×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

2604×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

3182×

VITAMN LBL

The food appears to be subject to section 411 and its advertising is false or misleading in a material respect or its labeling is in violation of section 411(b)(2).

Refusal History

Date	Product	Violations	Division
1/18/2011	41EFY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	262DIETARY 318VITAMN LBL 482NUTRIT LBL	Los Angeles District Office (LOS-DO)
1/18/2011	41EFY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	262DIETARY 318VITAMN LBL 482NUTRIT LBL	Los Angeles District Office (LOS-DO)
1/18/2011	41EFY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	260FALSE 262DIETARY 482NUTRIT LBL	Los Angeles District Office (LOS-DO)
1/18/2011	41EFY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	260FALSE 262DIETARY 482NUTRIT LBL	Los Angeles District Office (LOS-DO)
1/18/2011	41EFY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	260FALSE 262DIETARY 482NUTRIT LBL	Los Angeles District Office (LOS-DO)
1/18/2011	41EFY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	260FALSE 262DIETARY 482NUTRIT LBL	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Zhengtangzhuang Xiamen Healthcare Co., Ltd.'s FDA import refusal history?

Zhengtangzhuang Xiamen Healthcare Co., Ltd. (FEI: 3008438088) has 6 FDA import refusal record(s) in our database, spanning from 1/18/2011 to 1/18/2011.

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. Zhengtangzhuang Xiamen Healthcare Co., Ltd.'s FEI number is 3008438088.

What types of violations has Zhengtangzhuang Xiamen Healthcare Co., Ltd. received?

Zhengtangzhuang Xiamen Healthcare 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 Zhengtangzhuang Xiamen Healthcare Co., Ltd. come from?

All FDA import refusal data for Zhengtangzhuang Xiamen Healthcare 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.