Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

South Texas Botanicals Beeville, TX (3/29): FDA inspected the firm 10/2017 and cited the firm’s product labeling that promotes several of its dietary supplements that cause them to be drugs. For example, the firm promoted its Oral Health product for its pain reliving and healing properties. The company also promoted its LDMS Formula for “those who battle chronic depression.” The agency said its concerns were repeat findings from a 1/2017 inspection.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm603380.htm

Tris Pharma Monmouth Junction, NJ (3/26): FDA inspected the firm 2/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly investigate product failures and significant defect complaints. The firm also failed to establish adequate written procedures for production and process controls.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm603613.htm