Fibro Pharmaceutical Co Ltd

2 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 Fibro Pharmaceutical Co Ltd

Is Fibro Pharmaceutical Co Ltd on an FDA import alert?

Yes. As of October 25, 2026, Fibro Pharmaceutical Co Ltd is on the red list of FDA Import Alert 99-08, “Processed human and animal foods: pesticides”, for panax powder; FDA published the listing on September 16, 2009.

Has FDA refused shipments from Fibro Pharmaceutical Co Ltd?

Yes. FDA refused 1 shipment line from Fibro Pharmaceutical Co Ltd on November 6, 2017. The most recent, on November 6, 2017, was raw material for extracts and flavors, n.e.c., charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Fibro Pharmaceutical Co Ltd's shipments?

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

What is Fibro Pharmaceutical Co Ltd's FEI number?

Fibro Pharmaceutical Co Ltd's FDA Establishment Identifier (FEI) is 3004100740.

Can shipments from Fibro Pharmaceutical Co Ltd still enter the U.S.?

Shipments of panax powder from Fibro Pharmaceutical Co Ltd can be detained without physical examination under Import Alert 99-08; 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).