June 10, 2014 — The U.S. Food and Drug Administration (FDA) has filed a lawsuit against Mira Health Products Ltd. and its chief operating officer, Michael S. Ragno, for selling dietary supplements without properly testing ingredients from suppliers.
Last year, FDA inspectors observed numerous violations of current Good Manufacturing Practices (cGMP) standards. For example, the FDA found that Mira Health failed to establish that their suppliers’ certificates of analyses were reliable by confirming results of the suppliers’ tests or examinations.
The FDA also found that Mira Health failed to verify that finished batches of dietary supplements met product specifications for identity, purity, strength, and composition. Mira Health also failed to hold components, supplements, packaging, and labels in a way that does not lead to mix-ups, contamination, or deterioration.
According to the complaint (PDF):
“Although Defendants made some corrections in response to FDA’s inspection observations, they either did not follow through on their attempts to correct or failed to sustain the corrections they made, as shown by the ongoing, significant Dietary Supplement cGMP violations observed during the July 2013 inspection of the Defendants’ facility.”
The FDA is seeking to permanently restrain Mira Health from selling dietary supplements.
29 Injuries Linked to Recalled Mira Health Supplements
In August 2013, the FDA recalled the supplement Healthy Life Chemistry by Purity First B-50, manufactured by Mira Health. Although it was marketed as a vitamin B-50 supplement, it actually contained two harmful anabolic steroids (methasterone and dimethazine).
Anabolic steroids can have life-threatening side effects, including heart attack and stroke. The FDA received 29 reports of side effects, including:
- Muscle cramping
- Myalgia (muscle pain)
- Abnormal laboratory findings for liver and thyroid function
- Abnormal cholesterol levels
- Females had unusual hair growth and missed menstruation
- Men had erectile dysfunction and low testosterone
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