Drugs

Libby Laboratories CGMP Issues

A 3/11-3/14 FDA inspection at the Libby Laboratories drug manufacturing facility in Berkeley, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/27 Warning Letter says the specific violations were:

failure to conduct for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms; and
failure to conduct at least one test to verify the identity of each component of a drug product, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals.

FDA says Libby’s responses to the inspection observations were inadequate. It notes that the company’s quality systems are inadequate and recommends that Libby engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

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

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