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When inspecting a device manufacturing facility, FDA investigators will check a company's quality data to make sure it's Attributable, Legible, Contemporaneous, Original and Accurate – or "ALCOA," the agency's national device expert says.
Compliance Corner: US FDA Wants Device Firms To Fully Consider Risks To Consumers, Agency Expert Says
Manufacturers that don't consider all possible dangers their products can pose to consumers is a growing problem, FDA's national expert on devices says. Phil Pontikos also is worried that firms aren't putting their best foot forward when using risk assessment tools.
Two former US FDA investigators offer do's and don'ts for device firms to follow when their facilities are being inspected. Tips include everything from not boring an investigator during an opening meeting, to making sure quality system fixes are communicated to auditors in a timely fashion.
Device manufacturers should have appropriately skilled individuals fetching and handling electronic information to be handed over to US FDA investigators, says a former Johnson & Johnson quality & compliance expert. "The inspectional front room has to be able to manage live information, which means you have to have people who know the IT tools and how to navigate them, and how to find things quickly and explain them," Teresa Gorecki advises.
Referring to a US FDA investigator as an "inspector" might not seem like a big deal, but it is – and doing so can taint an inspection right from the start, industry insider Ricki Chase says. The former director of FDA’s Investigations Branch gives other pointers – including avoiding snatching investigator credentials and asking investigators if they're at the company to inspect the cafeteria. Another former FDA Investigations Branch director, David Chesney, chimes in, offering advice to ensure the best first impression.
Industry insider Steve Niedelman highlights eight points to consider that could ensure quicker, more efficient FDA inspections, including providing "clean" laptops for agency investigators, and making sure that opening presentations are complete and up-to-date.
Four industry experts – including a Medtronic quality VP and two former FDA investigators – offer advice on how device manufacturers can better ensure smooth sailing during an FDA audit.
Compliance Corner: Medtronic Quality Expert Urges Use Of Problem Statements When Investigating Device Failures – Plus Other Advice
Problem statements written before failure investigations occur can help device-makers organize their thoughts, fix things right the first time and ensure they aren't barking up the wrong tree, a Medtronic quality expert explains in this "Compliance Corner" feature. Also: a Q&A on CAPA effectiveness checks and root cause.
Are FDA investigators allowed to fish through a messy filing cabinet for documents? And do low-risk class III recalls play into an inspection? FDA investigator Ben Dastoli from the agency's Cincinnati, Ohio, district office, Cincinnati compliance officer Gina Brackett, and Monica Wilkins, divisional VP of QA/RA for device-maker Abbott Laboratories answer those queries and more from manufacturers.
Investigator Horror Stories: Industry Insiders Tell Of FDA Inspectional Nightmares – And How Device Firms Handled Them
In this "Compliance Corner" feature, two industry experts give real-world examples of potential FDA inspectional overreaches, including one investigator who followed a device firm's employee into a restroom to stop her from using a cell phone. Yes, that actually happened – and it's just one of many inspectional nightmares that manufacturers have faced when inspected by the agency.
FDA Investigators Tell What They Look For When Inspecting Facilities – But Device Firms Won't Choke If They Adequately Prepare
Device manufacturers are being reminded by FDA to make sure that everyone in their organization is familiar with procedures related to agency inspections – but firms will be able to handle that and more if they prepare for audits in advance, industry professional Connie Hoy points out. At device firm Cynosure, "we prepare the entire organization, from the CEO down, for an inspection and what to expect," she says in this Gray Sheet "Compliance Corner" feature.
Make Sure SOPs For FDA Inspections Are Robust, Industry Experts Say – And Don't Forget To Train The Receptionist
In this Gray Sheet "Compliance Corner" feature, Cynosure's Connie Hoy explains how standard operating procedures for FDA inspections are structured at her device manufacturing firm – and urges others to ensure they even have such procedures in the first place. "The purpose of that SOP is to direct the organization toward how you as a company – and the executive management of the company – expect to manage an FDA inspection, or any inspection, for that matter," she says.
Want A Quick Inspection? Have Records Prepped And Don't Dilly-Dally When Asked For Documents, FDA Investigators Advise
When 86 percent of FDA domestic inspections are preannounced, it's difficult to imagine that manufacturers could be caught unprepared – yet many do not have the appropriate records ready for investigators when they knock on the front door. And an auditor's suspicion might be aroused when it takes a long time to retrieve a particular document, says investigator Laureen Geniusz, who recommends manufacturer transparency: "If the record is stored in a cave in Pennsylvania, let the investigator know that's why it’s going to take a while to get it."
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