Progela, S.A. de C.V.

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

Refusal charges, in plain English

• UNAPPROVED2 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.

• NOT LISTED1 refused line

  Product not listed with FDA

  The product appeared to be a drug or device that is not included in the listing FDA requires under section 510(j) of the FD&C Act.

Questions about Progela, S.A. de C.V.

Is Progela, S.A. de C.V. on an FDA import alert?

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

Has FDA refused shipments from Progela, S.A. de C.V.?

Yes. FDA refused 2 shipment lines from Progela, S.A. de C.V. between February 3, 2021 and March 6, 2026. The most recent, on March 6, 2026, was vitamin b1 (thiamine), charged as NOT LISTED (product not listed with fda).

Why did FDA refuse Progela, S.A. de C.V.'s shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 2 lines) and NOT LISTED (product not listed with fda, 1 line).

What is Progela, S.A. de C.V.'s FEI number?

Progela, S.A. de C.V.'s FDA Establishment Identifier (FEI) is 3006134103.