Home » FDA Hands Warning Letters to Two Compounders
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.
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