FDA Hands Warning Letters to Two Compounders

Two compounders have landed FDA warning letters for the manufacture of unapproved, misbranded and adulterated drug products.

A March 30, 2015 to May 22, 2015, inspection found that Chatham, N.J.-based Liberty Drug & Surgical did not receive valid prescriptions for a portion of its sterile drug products.

The FDA deemed these products as unapproved new drugs, as Liberty did not have any agency-approved applications on file for the products and lacked valid prescriptions for individually identified patients, according to the letter.