Procaps S.A.

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

Refusal charges, in plain English

• LACKS FIRM1 refused line

  Manufacturer name and address missing

  The packaged product's label appeared not to show the name and place of business of the manufacturer, packer, or distributor.

• MFR INSAN1 refused line

  Insanitary manufacturing, processing or packing

  The product appeared to have been manufactured, processed, or packed under insanitary conditions, which is a ground for refusal under section 801(a)(1) of the FD&C Act.

• NO ENGLISH1 refused line

  Required label information not in English

  Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.

• 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 Procaps S.A.

Is Procaps S.A. on an FDA import alert?

No listing for Procaps S.A. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Colombia page.

Has FDA refused shipments from Procaps S.A.?

Yes. FDA refused 3 shipment lines from Procaps S.A. between May 2, 2017 and June 17, 2026. The most recent, on June 17, 2026, was vitamin e (tocopherol), charged as NO ENGLISH (required label information not in english).

Why did FDA refuse Procaps S.A.'s shipments?

The most frequent charges are LACKS FIRM (manufacturer name and address missing, 1 line) and MFR INSAN (insanitary manufacturing, processing or packing, 1 line).

When was Procaps S.A. last inspected by FDA?

FDA's most recent inspection of Procaps S.A. with a final classification is dated April 8, 2019 and was classified NAI (No Action Indicated).

What is Procaps S.A.'s FEI number?

Procaps S.A.'s FDA Establishment Identifier (FEI) is 3008338784.