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.

Absonutrix Greensboro, NC (7/25): FDA recently reviewed the firm’s Web site (www.absonutrix.com) and determined that dietary supplements marketed by the firm are considered new drugs based on claims found on the site. For example, one claim says: “When used in conjunction with Rolipram, Forskolin aids in the inhibition of colon cancer cell growth and survival.” Additionally, FDA objected to the site’s display of the agency’s logo that suggests an FDA endorsement of the site or its products.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm568862.htm

Medical Center Pharmacy Cleveland, TN (7/21): FDA inspected the firm’s drug compounding operation 9/2015 and cited serious deficiencies in its practices for producing sterile drug products. Specifically, the firm failed to meet conditions that allow for drug compounding, such as not receiving valid prescriptions for individually-identified patients for a portion of the drug products produced.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm568565.htm