Drugs

Global Calcium CGMP Deviations

A 7/29-8/2/2024 FDA inspection at the Global Calcium drug manufacturing facility in Tamil Nadu, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 1/16 Warning Letter says the specific deviations were:

failure of the firm’s quality unit to prepare, review, and approve documents related to the manufacturing of APIs following written procedures;
failure to properly maintain buildings and facilities used in the manufacture of APIs; and
failure to establish an impurity profile for identified and unidentified impurities.

FDA recommends the firm engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. It notes it placed a 12/20/2024 Import Alert on the firm’s products.

Global Calcium was told to correct deviations promptly and to respond with a list of specific actions it has taken to address the deviations 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

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome