Drugs

Warning Letters Focus on Document Control, Data Integrity

Recent Warning Letters show that document control and data integrity (as well as complaint handling and corrective and preventive actions) remain key concerns of FDA investigators, according to an analysis by AssurX. “Today, FDA cGMPs and ISO standards require a document control system that demonstrates product safety and reliability,” the group says. “Automated systems drive processes that integrate workflow and data capture with applications, databases, notifications and tracking. Getting rid of paper and investing in the right electronic solution can eliminate untold outlays for compliance violations.”

To illustrate FDA concerns, AssurX reviewed a 2/24 Warning Letter to Megafine Pharma that cited a lack of document control, including:

Failure to control the issuance, revision, superseding, and withdrawal of all documents by maintaining revision histories
Failure to establish and follow adequate written procedures for cleaning equipment and its release for use in API manufacture, and to maintain adequate records of major equipment usage

Another Warning Letter cited by Assurx that highlights the agency’s concerns was issued to medical device maker Denttio. The letter noted several document control system compliance issues including:

Failure to establish a design history file
Failure to provide records to demonstrate that it had conducted a risk analysis to identify potential hazards and control measures
Failure to implement and maintain device master records
Failure to establish procedures for finished device and incoming product acceptance

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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