Sun Ten Pharmaceutical Co., Ltd.

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

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 Sun Ten Pharmaceutical Co., Ltd.

Is Sun Ten Pharmaceutical Co., Ltd. on an FDA import alert?

Yes. As of October 26, 2026, Sun Ten Pharmaceutical Co., Ltd. is on the red list of FDA Import Alert 54-16, “Foods/supplements with active pharmaceutical ingredient”, for red yeast rice; FDA published the listing on February 17, 2016.

Has FDA refused shipments from Sun Ten Pharmaceutical Co., Ltd.?

Yes. FDA refused 1 shipment line from Sun Ten Pharmaceutical Co., Ltd. on February 27, 2025. The most recent, on February 27, 2025, was herbals & botanicals (not teas), n.e.c., charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Sun Ten Pharmaceutical Co., Ltd.'s shipments?

The most frequent charge is UNAPPROVED (unapproved new drug, 1 line).

When was Sun Ten Pharmaceutical Co., Ltd. last inspected by FDA?

FDA's most recent inspection of Sun Ten Pharmaceutical Co., Ltd. with a final classification is dated December 12, 2017 and was classified NAI (No Action Indicated).

What is Sun Ten Pharmaceutical Co., Ltd.'s FEI number?

Sun Ten Pharmaceutical Co., Ltd.'s FDA Establishment Identifier (FEI) is 3010184955.

Can shipments from Sun Ten Pharmaceutical Co., Ltd. still enter the U.S.?

Shipments of red yeast rice from Sun Ten 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).