Drugs

API Deviations Seen in Alchymars Inspection

A 9/11-9/15/17 FDA inspection at Alchymars ICM SM Private Limited, Chennai, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to a 2/16 Warning Letter. Specific deviations cited in the letter were:

failing to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure API compliance with established specifications and standards;
failing to properly maintain equipment and to keep complete records of major equipment maintenance;
failure of the quality unit to ensure that quality-related complaints are investigated and resolved;
failing to properly maintain buildings and facilities used in the manufacture of intermediates and API; and
failure to provide personnel with adequate clean washing and toilet facilities.

The letter says FDA cited similar deviations following a 2/2-2/6/15 inspection and said that while the company proposed specific remediation for those deviations, repeated deficiencies “demonstrate that your facility’s oversight and control over the manufacture of drugs is inadequate.” FDA recommends that the firm engage a qualified consultant to assist it in meeting CGMP requirements.

The firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured, FDA says. It calls for a comprehensive investigation into the extent of inaccuracies in data records and reporting, a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs, and a management strategy that includes details of the firm’s global corrective action and preventive action plan.

Alchymars was told to respond with a list of specific actions taken since the inspection to correct the deviations and prevent their recurrence.

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