Drugs

Boehringer Ingelheim Inspection Report Posted

FDA has just posted the establishment inspection report issued following a 5/29-6/9/2023 inspection at the Boehringer Ingelheim drug manufacturing facility in Shanghai, China. The report says it covered the initial inspection of the facility and was limited to the manufacturing of a redacted drug substance and product in a specific building.

The seven inspection observations were:

failure to have in writing and fully follow the responsibilities and procedures applicable to the firm’s quality unit;
failure to establish and follow appropriate visual inspection procedures designed to assure batches of products meet appropriate specifications and statistical quality control criteria as a condition for their approval and release;
failure to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failure to exercise appropriate controls to protect the electronic data acquisition and/or manufacturing control systems used for drug substance and drug product manufacturing;
the current drug substance manufacturing practices present a high risk for potential contamination;
failure to have written records of investigations into unexplained discrepancies, the failure of a batch or any of its components to meet specifications, to include appropriate conclusions and follow-ups; and
failure of laboratory controls to include the establishment of scientifically sound and appropriate standards designed to assure that components and in-process materials conform to appropriate standards of identity, strength, quality, and purity.

An additional 11 investigator concerns were discussed with the firm’s management during the close-out meeting, FDA says.

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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