Mama mia! FDA busts Abba for GMP and labeling violations

By Shane Starling

- Last updated on GMT

Related tags: Dietary supplement, Vitamin, Fda

Not Bjorn yesterday: The FDA has slapped Abba with a host of GMP and labeling breaches
Not Bjorn yesterday: The FDA has slapped Abba with a host of GMP and labeling breaches
The FDA has issued a warning letter to Florida-based dietary supplement manufacturer Abba Pharma over manufacturing, packaging and labeling violations.

It said the company had breached sections 201 and 402 and 403 of the Federal Food, Drug, and Cosmetic Act [the FDCA] for a range of products and gave the company 15 days to rectify the situation. The letter was sent February 9 this year.

On the labeling front, Abba was found to have made unauthorized drug claims for Proteinex and Nephronex that contravened section 201, 502 and 301 of the FDCA. These included claims that Nephronex could benefit those on dialysis treatment and that Proteinex could help heal wounds and burns and those with HIV/AIDS and cancer.

On the manufacturing front, FDA inspections and product sample analysis revealed section 403 violations because products contained higher levels of, phosphorus, sodium, and potassium … than the amounts declared on the product labels.”

The analysis revealed products with 200mg or more of these substances despite labels usually claiming zero levels.

Section 402 GMP violations included:

  • Failure to test every finished product batch or, “a subset of the finished dietary supplement batches that you identify through a sound statistical sampling plan to determine whether the finished product meets established product specifications for identity, purity, strength, and composition of the dietary supplement”
  • Failure to clarify Standard Operating Procedures for final product testing. “Your records indicate that you performed microbiological tests on the finished product, but this type of test does not verify the identity, purity, strength, and composition of the finished product.”
  • Failure to establish component specifications for, “Thiamine HCl, Riboflavin Phosphate, Pyridoxine HCl, Cyanocobalamin, Ascorbic Acid, Folic Acid, Niacinamide, D-Biotin, Calcium D-Pantothenate, Propylene Glycol USP, Glycerine 99.5%, Methylparaben, Propylparaben, Potassium Sorbate, Cremophor RH40, Triethanolamine, Aspartame, Orange Oil, and Purified Water”.
  • Failure to identify ingredient identity testing protocols. “Your response does not specify, and you did not provide, supporting documentation on how you intend to ensure that you will verify the identity of each dietary ingredient used in the dietary supplements you manufacture.”
  • Failure to establish and follow written procedures for, “calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement. Specifically, you did not have records of calibration for the scales used to weigh raw materials in the manufacturing of your dietary supplement products.”
  • Failure to follow a written master manufacturing record (MMR) for each formulation and batch size
  • Water use did not meet GMP requirements

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