Drugs

Multiple Violations at Persōn & Covey

A 1/27-2/26 FDA inspection at the Persōn & Covey drug manufacturing facility in Glendale, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. The inspection also found that two of the firm’s drug products are legally considered to be unapproved new drugs. A 9/23 Warning Letter says the specific CGMP violations were:

failure of the firm’s quality control unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity;
failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
failure to establish adequate written procedures for production and process control designed to ensure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess.

FDA recommends that the firm retain a qualified consultant to assist it in meeting CGMP requirements. It also notes that Xerac AC and Drysol are considered to be drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. It says the products are not generally recognized as safe and effective and the company does not have an approved application for either of them.

The letter also notes that some of the firm’s products may be regulated as cosmetics.

Persōn & Covey was told to correct the violations promptly and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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