Alopecil Corporation, S.R.L.

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

Refusal charges, in plain English

• SUPPL GMP12 refused lines

  Dietary supplement CGMP not met

  The product appeared to be a dietary supplement prepared, packed, or held under conditions that do not meet current good manufacturing practice (CGMP) regulations.

• LIST INGRE10 refused lines

  Ingredients not listed

  The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).

• NCONTACT10 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.

• NUTRIT LBL10 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.

• UNSAFE COL9 refused lines

  Color additive unsafe under section 721

  The product appeared to be, or to contain, a color additive that is unsafe within the meaning of section 721(a) of the FD&C Act, the section that governs which color additives may be used and how.

• DIETARYLBL8 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).

• ALLERGEN7 refused lines

  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.

• FALSE7 refused lines

  False or misleading labeling

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

Questions about Alopecil Corporation, S.R.L.

Is Alopecil Corporation, S.R.L. on an FDA import alert?

Yes. As of October 26, 2026, Alopecil Corporation, S.R.L. is on the red list of FDA Import Alert 54-14, “Supplements from firms not meeting supplement GMP”, for balsamic honey syrup; watercress and onion radish honey syrup (herro y cebolla); punch natural; FDA published the listing on November 10, 2016.

Has FDA refused shipments from Alopecil Corporation, S.R.L.?

Yes. FDA refused 22 shipment lines from Alopecil Corporation, S.R.L. between January 12, 2017 and March 25, 2026. The most recent, on March 25, 2026, was herbals & botanicals (not teas), n.e.c., charged as SUPPL GMP (dietary supplement cgmp not met).

Why did FDA refuse Alopecil Corporation, S.R.L.'s shipments?

The most frequent charges are SUPPL GMP (dietary supplement cgmp not met, 12 lines) and LIST INGRE (ingredients not listed, 10 lines).

When was Alopecil Corporation, S.R.L. last inspected by FDA?

FDA's most recent inspection of Alopecil Corporation, S.R.L. with a final classification is dated June 8, 2016 and was classified OAI (Official Action Indicated).

What is Alopecil Corporation, S.R.L.'s FEI number?

Alopecil Corporation, S.R.L.'s FDA Establishment Identifier (FEI) is 3010098874.

Can shipments from Alopecil Corporation, S.R.L. still enter the U.S.?

Shipments of balsamic honey syrup; watercress and onion radish honey syrup (herro y cebolla); punch natural from Alopecil Corporation, S.R.L. can be detained without physical examination under Import Alert 54-14; 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).