Drugs

CGMP Violations at Tismor Health and Wellness

A 5/20-5/24/19 FDA inspection at Tismor Health and Wellness, Kingsgrove, Australia, found significant violations of current good manufacturing practice (CGMP) regulations in the firm’s work as a contractor producing finished drugs. A just-released 12/5/19 Warning Letter says specific violations were:

failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records or other records;
failing to establish written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug products conform to appropriate standards of identity, strength, quality, and purity.

The letter reminds Tismor that it is responsible for the quality of drugs it produces as a contract facility regardless of agreements in place with the product owners. It also says that 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 it manufactures.

FDA acknowledged that Tismor is using a consultant to audit its operations and assist in meeting FDA requirements and asked for:

a comprehensive investigation into the extent of data record and reporting inaccuracies;
a current risk assessment of the potential effects of the observed failures on the quality of the drugs produced; and
a management strategy for the firm that includes the details of its global corrective and preventive action plan.

The letter also raises an agency concern with a Tismor drug product that contains glycerin and with its unapproved new drug. The company was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence and a schedule for implementation of the actions.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome