Biocol Pharma, Lda

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

Refusal charges, in plain English

• FALSE91 refused lines

  False or misleading labeling

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

• NUTRIT LBL8 refused lines

  Nutrition information missing from label

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

• UNAPPROVED8 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.

• LABELING4 refused lines

  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.

• NCONTACT4 refused lines

  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.

• DIETARYLBL2 refused lines

  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).

• INCONSPICU2 refused lines

  Required information not conspicuous

  Information required on the label appeared not to be placed prominently or conspicuously enough to be read and understood by an ordinary consumer.

• ALLERGEN1 refused line

  Major food allergen not declared

  The label appeared not to declare all major food allergens present in the product, as section 403(w) of the FD&C Act requires.

Questions about Biocol Pharma, Lda

Is Biocol Pharma, Lda on an FDA import alert?

Yes. As of October 25, 2026, Biocol Pharma, Lda is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for something for a detox week dietary supplement; FDA published the listing on November 7, 2024.

Has FDA refused shipments from Biocol Pharma, Lda?

Yes. FDA refused 110 shipment lines from Biocol Pharma, Lda between March 1, 2018 and August 13, 2026. The most recent, on August 13, 2026, was herbals & botanicals (not teas), n.e.c., charged as FALSE (false or misleading labeling).

Why did FDA refuse Biocol Pharma, Lda's shipments?

The most frequent charges are FALSE (false or misleading labeling, 91 lines) and NUTRIT LBL (nutrition information missing from label, 8 lines).

When was Biocol Pharma, Lda last inspected by FDA?

FDA's most recent inspection of Biocol Pharma, Lda with a final classification is dated September 25, 2024 and was classified VAI (Voluntary Action Indicated).

What is Biocol Pharma, Lda's FEI number?

Biocol Pharma, Lda's FDA Establishment Identifier (FEI) is 3030442120.

Can shipments from Biocol Pharma, Lda still enter the U.S.?

Shipments of something for a detox week dietary supplement from Biocol Pharma, Lda can be detained without physical examination under Import Alert 99-39; 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).