Drugs

Multiple Violations in DermaRite Inspection

A 3/16-4/6 FDA inspection at the DermaRite Industries drug manufacturing facility in North Bergen, NJ, found multiple violations in the firm’s production of over-the-counter drugs, including significant violations of current good manufacturing practice (CGMP) regulations. A just-released 13-page 10/27 Warning Letter says the CGMP violations were:

failure to thoroughly investigate any unexplained discrepancy or failure of a batch of any of its components to meet any of its specifications, whether or not the batch has already been distributed;
failure to test samples of each component for identity and conformity with appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products, and to use results of stability testing to determine appropriate storage conditions and expiration dates; and
failure of the quality control unit to exercise its responsibility to ensure that drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter also discusses multiple unapproved new drug and misbranded drug violations for several of the firm’s over-the-counter products. It says some of the firm’s products may be regulated as cosmetics, which must meet applicable statutory and regulatory requirements.

FDA recommends that DermaRite engage a qualified consultant to assist it in meeting CGMP requirements.

The company was told to correct 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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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