Drugs

Owen Biosciences CGMP Violations

A 3/25-3/27 FDA inspection at the Owen Biosciences drug manufacturing facility in Baton Rouge, LA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/20 Warning Letter says the specific violations were:

failure to establish laboratory controls that include scientifically sound and appropriate specifications designed to assure drug products conform to appropriate standards of identity, strength, quality, and purity, and failure to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for drug products before release;
failure to establish an adequate written testing program designed to assess the stability characteristics of drug products; and
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.

The letter notes that Owen and a redacted product distributor failed to abide by a commitment to recall a benzoyl peroxide acne lotion product lot that FDA tested and found contained excessive benzene impurity levels.

FDA recommends that Owen engage a qualified consultant to assist it in meeting CGMP requirements. It also points out that Owen is responsible for the quality of drugs it produces as a contract facility, regardless of agreements in place with the product owners.

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

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