SciLabs gets sued by the FDA

The FDA last week  sued dietary supplement manufacturer SciLabs Nutraceuticals Inc. and its senior executive with a lawsuit in California federal court for allegedly failing to properly test its ingredients and establish quality control procedures.
SciLabs and its Chief Executive Officer Paul Edalat violated the Federal Food, Drug and Cosmetic Act by manufacturing and distributing adulterated dietary supplements, according to the FDA. The company makes dietary supplements under the brand name All Pro Science, the agency told the court.

The FDA is seeking injunctive relief.   The Complaint is here:

The FDA conducted multiple inspections of the company’s facilities, and claimed it found multiple deviations of the Federal Food, Drug and Cosmetic Act. Warning letters go back to 2010, and as recent as 2013. A warning letter issued that year says, in part:


The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located at 17809 Gilette Ave., Irvine, CA, on July 31, 2012 through August 14, 2012. The inspection identified serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet the CGMP regulation for dietary supplements.

The inspection also revealed violations of dietary supplement labeling requirements, rendering your Duzoxin Secret to Slim, Punishment Nutrition and Whey Protein Isolate products misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)].
Dietary Supplement CGMP Violations
  1. Your firm did not establish required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70.
Once you have established the above specifications, you must determine whether the specifications have been met, as required by 21 CFR 111.73 and 111.75.
  1. Before using components in manufacturing your dietary supplements, you failed to meet the requirements of 21 CFR 111.75(a). For example:
  • You did not conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by [21 CFR 111.75(a)(1)(i)]. Specifically, your firm did not test or verify the identity of the Instant Whey Protein and Glutamine used to manufacture your N-Large 2 and Nutritech products.
  • You did not confirm the identity of other components, as required by [21 CFR 111.75(a)(2)]. Specifically, your firm relied on your suppliers’ Certificate of Analysis (COA), but you have not qualified the suppliers, of the Maltrin, Maltodextrin, Fructose, Sucralose components used in your N-Large 2 product and Flo-Gard AB, Magnesium Stearate, Rice White Flour, and Clear Bovine Capsules components used in your Nitrogen Glutamine capsules.
We have reviewed your response, dated September 5, 2012, and found it to be inadequate. You state that you will issue testing specifications for incoming dietary ingredients as well as update your current raw material supplier verification program to reflect the updated qualification of ingredient suppliers. However, you did not provide the proposed testing specification or any adequate supporting documents to evaluate your corrective actions.
  1. Your firm did not prepare and follow a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured, as required by 21 CFR 111.205 and in accordance with 21 CFR 111.210.
We have reviewed your response, dated September 5, 2012, and found it to be inadequate. You have submitted a SOP but you failed to include an example of the document that will be maintained as your firm’s master manufacturing record.

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