Drugs

Repeat CGMP Issues at Miers Laboratories

A 5/19-5/21 FDA inspection at the Miers Laboratories drug manufacturing facility in Wellington, New Zealand, found repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/3 Warning Letter says the two specific violations were:

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 the component supplier’s test analyses at appropriate intervals; 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 says similar CGMP violations were cited following a 2019 inspection. “You acknowledged these observations and informed our investigators that you would correct all observations during the closeout meeting,” it says. “Despite these commitments, when FDA reinspected your facility, the violations had not been corrected. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

Because of the repeated violations, FDA recommends that Miers retain a qualified consultant to assist it in meeting CGMP requirements.

The company was told to correct the violations promptly and to provide a list of specific actions it has taken to address them and prevent their recurrence, along with a schedule for completing the corrections.

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