Agepha Pharma S.R.O.

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

Refusal charges, in plain English

• UNAPPROVED3 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.

• HEALTH C1 refused line

  Unauthorized nutrient content or health claim

  The label or labeling appeared to carry a nutrient content claim or health claim that is not authorized.

• LACKS N/C1 refused line

  Net quantity statement missing

  The packaged food appeared not to carry an accurate statement of the quantity of contents, such as net weight, measure, or count, on its label.

Questions about Agepha Pharma S.R.O.

Is Agepha Pharma S.R.O. on an FDA import alert?

No listing for Agepha Pharma S.R.O. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Slovakia page.

Has FDA refused shipments from Agepha Pharma S.R.O.?

Yes. FDA refused 4 shipment lines from Agepha Pharma S.R.O. between May 13, 2024 and October 22, 2024. The most recent, on October 22, 2024, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Agepha Pharma S.R.O.'s shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 3 lines) and HEALTH C (unauthorized nutrient content or health claim, 1 line).

What is Agepha Pharma S.R.O.'s FEI number?

Agepha Pharma S.R.O.'s FDA Establishment Identifier (FEI) is 3017156886.