CGMP Deviations in Macsen Drugs Inspection

A 9/2-9/6/2024 FDA inspection at the Macsen Drug manufacturing facility in Tehsil Mavli, Udaipur, Rajastahn, India, identified significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 3/25 Warning Letter says the specific violations were:

• failure of the quality unit to exercise its responsibility to ensure the manufactured APIs comply with CGMP; and
• failure of the quality unit to ensure that there is stability data to support retest or expiry dates and storage conditions of APIs.

The firm’s responses to the inspection observations were inadequate, FDA says. The agency told Macsen to correct all deviations promptly and to respond with a list of specific actions it has taken to correct the deviations and prevent their recurrence, with a schedule for completing the corrections.