Drugs

Multiple Violations at Elite One Source

A 9/14-28 FDA inspection at Nutritional Laboratories International, doing business as Elite One Source Nutritional Services, Missoula, MT, identified serious violations of the Federal Food, Drug, and Cosmetic Act and applicable regulations. An 8/5 Warning Letter says the inspection found serious violations of the current good manufacturing practice (CGMP) regulations for manufacturing, packaging, labeling, or holding operations for dietary supplements, causing the supplements to be adulterated. Specific violations cited were:

failing to verify, for a subset of finished dietary supplement batches identified through a sound statistical sampling plan that the finished batch meets product specifications for identity, purity strength, composition, and for limits on those types of contamination that may adulterate or lead to adulteration of the finished batch of the dietary supplement;
failure of the firm’s quality control personnel to follow written procedures for the responsibilities of the quality control operations;
failing to verify that the laboratory examination and testing methodologies are appropriate for their intended use; and
failing to establish and follow laboratory control processes for selecting standard reference materials used in performing tests and examinations.

The letter also says the firm’s products are misbranded because they do not comply with labeling requirements for dietary supplements. Specific misbranding violations were:

the serving size declared on the label is incorrect;
the presentation of nutrition information on the labeling does not comply with regulations; and
source ingredients and a dietary ingredient fail to be declared on the label by the common or usual name.

Elite One Source was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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