Drugs

Dietary Supplement Violations Found in Marco Pharma Inspection

A 5/14-5/22/19 FDA inspection at Marco Pharma, Roseburg, OR, found serious violations of current good manufacturing practice (CGMP) regulations for dietary supplements. A 1/10 Warning Letter says significant violations were:

failing to establish the required specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record;
failing to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and approving or rejecting any reprocessing;
failing to include information required by regulations in the Master Manufacturing Records for the dietary supplement products the company packages and labels;
failing to have batch production records include the required information relating to the production and control of each batch; and
failing to calibrate instruments and controls used in manufacturing or testing a component or dietary supplement.

The letter also says that several of the firm's dietary supplement products are misbranded because they do not comply with labeling requirements for dietary supplements.

Marco was told to take prompt action to correct the violations and to respond with a list of specific actions taken to correct the violations, documentation for each action, and a schedule for completion. The company was told that FDA can assess and collect fees for costs associated with a re-inspection.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome