Biotivity SDN BHD

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

Refusal charges, in plain English

• UNAPPROVED7 refused lines

  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.

• DIRECTIONS2 refused lines

  DIRECTIONS

• FALSE2 refused lines

  False or misleading labeling

  The labeling appeared to be false or misleading in some particular.

• FRNMFGREG2 refused lines

  FRNMFGREG

• DIETARYLBL1 refused line

  Not identified as a dietary supplement

  The label appeared not to identify the product with the term "dietary supplement" (which may be modified with the name of an ingredient).

• LABELING1 refused line

  Fair Packaging and Labeling Act

  The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.

• NCONTACT1 refused line

  No U.S. adverse event contact on supplement label

  The dietary supplement label appeared not to show a U.S. address or phone number through which a serious adverse event can be reported.

• NUTRIT LBL1 refused line

  Nutrition information missing from label

  The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

Questions about Biotivity SDN BHD

Is Biotivity SDN BHD on an FDA import alert?

Yes. As of October 26, 2026, Biotivity SDN BHD is on the red list of FDA Import Alert 54-16, “Foods/supplements with active pharmaceutical ingredient”, for royal honey vip; FDA published the listing on June 29, 2017.

Has FDA refused shipments from Biotivity SDN BHD?

Yes. FDA refused 10 shipment lines from Biotivity SDN BHD between June 29, 2017 and February 19, 2021. The most recent, on February 19, 2021, was honey, n.e.c., charged as POISONOUS (poisonous or deleterious substance).

Why did FDA refuse Biotivity SDN BHD's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 7 lines) and DIRECTIONS (directions, 2 lines).

What is Biotivity SDN BHD's FEI number?

Biotivity SDN BHD's FDA Establishment Identifier (FEI) is 3011924945.

Can shipments from Biotivity SDN BHD still enter the U.S.?

Shipments of royal honey vip from Biotivity SDN BHD 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).