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Jiangsu Shenhua Pharmaceutical Co., Ltd

FDA import alert and refusal historyHuaian, ChinaFEI 3012130479

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Example subjectJiangsu Shenhua Pharmaceutical Co., Lt added to Import Alert 16-129 (red list)

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As of October 27, 2026, Jiangsu Shenhua Pharmaceutical Co., Ltd (Huaian, China) is on the red list of FDA Import Alert 54-16 (Foods/supplements with active pharmaceutical ingredient) for cordyceps extract powder, published by FDA on September 22, 2023, and has 1 FDA import refusal recorded since October 2016.

Data from FDA public records, last checked . Request a correction

Current status

Last import refusal
Herbals & botanicals (not teas), n.e.c. · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Jiangsu Shenhua Pharmaceutical Co., Ltd

2 records, newest first. Each line links to the FDA page it came from.

2026

  1. Import refusal
    Refused, Herbals & botanicals (not teas), n.e.c.UNAPPROVEDEntry W69-5221285-1
    Source

2023

  1. Import alert listing
    Listed on Import Alert 54-16red listCordyceps extract powder
    Source

Refusal charges, in plain English

  • UNAPPROVED1 refused line

    Unapproved new drug

    The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

Questions about Jiangsu Shenhua Pharmaceutical Co., Ltd

Is Jiangsu Shenhua Pharmaceutical Co., Ltd on an FDA import alert?
Yes. As of October 27, 2026, Jiangsu Shenhua Pharmaceutical Co., Ltd is on the red list of FDA Import Alert 54-16, “Foods/supplements with active pharmaceutical ingredient”, for cordyceps extract powder; FDA published the listing on September 22, 2023.
Has FDA refused shipments from Jiangsu Shenhua Pharmaceutical Co., Ltd?
Yes. FDA refused 1 shipment line from Jiangsu Shenhua Pharmaceutical Co., Ltd on August 14, 2026. The most recent, on August 14, 2026, was herbals & botanicals (not teas), n.e.c., charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Jiangsu Shenhua Pharmaceutical Co., Ltd's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 1 line).
What is Jiangsu Shenhua Pharmaceutical Co., Ltd's FEI number?
Jiangsu Shenhua Pharmaceutical Co., Ltd's FDA Establishment Identifier (FEI) is 3012130479.
Can shipments from Jiangsu Shenhua Pharmaceutical Co., Ltd still enter the U.S.?
Shipments of cordyceps extract powder from Jiangsu Shenhua Pharmaceutical Co., Ltd can be detained without physical examination under Import Alert 54-16; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).

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Example subjectJiangsu Shenhua Pharmaceutical Co., Lt added to Import Alert 16-129 (red list)

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.