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A recent FDA Warning Letter illustrates to sponsors the importance of properly managing monitoring responsibilities and having a thorough site activation process. In this article, we’ll examine the letter received by the sponsor of a multisite trial of a device for preventing recurrent ischemic stroke and discuss how problems could have been avoided in the first place. Read More
This excerpt is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, A WCG Company. The presenter was David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting. Read More
AMCO International Manufacturing & Design received an FDA Warning Letter because automated external defibrillator (AED) replacement batteries made by the firm have not received FDA approval. Read More
This Q and A is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, A WCG Company. The presenter was David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting. Read More
FDA issued a Warning Letter to Criticare Technologies for failure to investigate complaints that its nGenuity patient vital signs monitor — which can be used during surgery — had shut off intermittently. Read More
In this edition of Quick Notes, we cover a workshop on psychedelics, regulations on substances of human origin, selection of the COVID-19 strain for the next vaccines and a 483 for Swiss company Lonza. Read More
The FDA significantly increased foreign inspections in fiscal 2023 while domestic inspections remained flat, according to the agency’s latest annual inspection report. Read More
The FDA has sent an additional warning letter to China-based Jiangsu Shenli Medical Production for quality system violations for its enteral syringe products and expanded the company’s import alert to prevent their enteral syringes from entering the US. Read More
Parameters for slowing or blocking an FDA drug or device inspection are now available to manufacturers and storage facilities, following the agency’s release of its final guidance on the subject Friday. Read More
Understanding what documents you must provide to the FDA during an inspection — and what’s off limits to the agency — is a key to timely and effective responses, according to inspections expert David Chesney. Read More
One of the biggest mistakes companies make in their responses to the FDA’s inspection observations is to focus on the specific issues raised without looking at the bigger picture, according to one regulatory compliance expert. Read More