Just released from FDAnews — Investigations Operations Manual 2014 — the FDA’s own internal guidance on how to inspect a drug or device company. Know what the investigators look for — before they even get there.
Websites, medical meetings, television talk shows, trade shows . . . wherever your products are being mentioned, chances are good the FDA is watching and looking for violations of the rules covering promotions. And with the agency cranking out three more social media guidances in 2014, you can expect even more challenges in the way the FDA evaluates promotions in the months ahead. Now’s the time to take stock of your promotional review practices and see if they’re really covering all the places they need to – even those you might least expect. And what you can do about it if they’re not.
Corrective and preventive action (CAPA) procedures at Biopsy Sciences’ Clearwater, Fla., facility do not ensure analysis of all quality data sources to identify “recurring” quality problems with its HydroMARK breast biopsy site marker and other devices, an FDA Form 483 states. FDA investigators also note in the Sept. 15, 2011, form that when Biopsy Sciences receives a complaint, CAPAs are not always taken to conduct a full investigation to determine root cause. The GMP Letter