FDA Warns Biotek for Marketing Misbranded Drugs, GMP Violations
FDA issued a warning letter to Biotek after a review of its website found some of its products were intended for use as drugs.
The company, based in Layton, Utah, claimed one product could protect against toxic reaction and heavy metal poisoning and another helped with restless leg syndrome and muscle cramps.
The FDA did not find the products to be safe or effective for their intended uses and declared them misbranded.
An August 2017 inspection of the Biotek facility also revealed numerous GMP violations. The facility lacked quality control written procedures for repacking, labeling, holding and distributing. The company said it would correct the deficiencies in three months, but did not say how or provide any documentation.
The facility also failed to ensure accurate labeling of its dietary supplements. Some products contained ingredients that did not match those listed on the labels.
The agency also found that the firm could not provide assurance that the products it received from a supplier for packaging or labeling were consistent with the purchase order.