FDA Warning Letters Week of 11/24/2019: Repackaging and CBD Products

This week, FDA issued warning letters to 15 firms, (here is an example), that sell CBD products.  These letters were issued by the Center for Food Safety and Applied Nutrition which govern nutritional supplements.  FDA cites its authority over interstate commerce for food.  The warning letters were based on reviews of websites which made claims consistent with drugs, and so they were also cited for distribution of unapproved new drugs.  They are also misbranded because they do not include appropriate instructions for use.  So, products are adulterated, unapproved new drug, and misbranded.  On a related note, FDA published a revised consumer update that addresses safety issues associated with CBD products.

The FDA posted one warning letter to a pharmaceutical firm which we cover below.

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DRUGS | Lohxa LLC

Lohxa LLC (Worcester, MA) received a warning letter on September 10, 2019 based on the outcome of an inspection ending March 22, 2019.  The company website identifies the firm as a repackager that provides “customized labeling, packaging and bar-coding capabilities.”  While not identified as a deficiency per se, the FDA notes that the firm’s quality systems are inadequate and points them to the FDA guidance on Quality Systems.

Deficiencies include but are not limited to:

• Labeled expiry date of 12 months, after re-packaging, is not supported by stability data. The firm noted that expiry of 12 months for one product was assigned in error and should have been 6 months, and recalled four lots.
• The firm failed to clean and maintain equipment.  The firm could not provide cleaning validation protocols, data or reports to support cleaning validation.  Cleaning procedures were not available for review.  Of particular concern is the mention of non-dedicated equipment that is shared among highly potent APIs including atropine.
• Investigations into complaints do not describe the event, do not describe the investigation and do not provide documented evidence supporting the conclusion.