Latest FDA Warning Letter

FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below:

LifeHealth Science, Twinsburg, OH (5/15): FDA inspected the company 11/2020 and found multiple serious violations in the firm’s manufacturing and distribution of its OREA dietary supplement. It says that claims on the firm’s Web site establish that the product is considered to be a drug that is intended for use in the care, mitigation, treatment, or prevention of disease. FDA also cited violations of GMP requirements for dietary supplements. For example, LifeHealth failed to establish product specifications for each dietary supplement manufactured for the identity, purity, strength, and composition of the finished batch of the dietary supplement. Additionally, it failed to establish component specifications. To view the letter, click here.