Omega Alpha Pharmaceuticals

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

Refusal charges, in plain English

• SUPPL GMP14 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.

• UNSAFE ADD8 refused lines

  Food additive unsafe under section 409

  The product appeared to contain a food additive that is unsafe within the meaning of section 409 of the FD&C Act, the section that governs which food additives may be used and under what conditions.

• FALSE5 refused lines

  False or misleading labeling

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

• 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.

• DIRSEXMPT1 refused line

  DIRSEXMPT

• LABELING1 refused line

  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.

• 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.

• LIST INGRE1 refused line

  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).

Questions about Omega Alpha Pharmaceuticals

Is Omega Alpha Pharmaceuticals on an FDA import alert?

Yes. As of October 25, 2026, Omega Alpha Pharmaceuticals is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for aeolus lung cleanse; maculex; FDA published the listing on July 6, 2020.

Has FDA refused shipments from Omega Alpha Pharmaceuticals?

Yes. FDA refused 26 shipment lines from Omega Alpha Pharmaceuticals between January 9, 2018 and November 30, 2023. The most recent, on November 30, 2023, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as SUPPL GMP (dietary supplement cgmp not met).

Why did FDA refuse Omega Alpha Pharmaceuticals's shipments?

The most frequent charges are SUPPL GMP (dietary supplement cgmp not met, 14 lines) and UNSAFE ADD (food additive unsafe under section 409, 8 lines).

When was Omega Alpha Pharmaceuticals last inspected by FDA?

FDA's most recent inspection of Omega Alpha Pharmaceuticals with a final classification is dated February 24, 2022 and was classified OAI (Official Action Indicated).

What is Omega Alpha Pharmaceuticals's FEI number?

Omega Alpha Pharmaceuticals's FDA Establishment Identifier (FEI) is 3010129381.

Can shipments from Omega Alpha Pharmaceuticals still enter the U.S.?

Shipments of aeolus lung cleanse; maculex from Omega Alpha Pharmaceuticals 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).