As noted on its site, the FDA conducts several types of inspections to help provide access to needed medical products and to protect consumers and patients from unsafe products. There are four types of inspections that medical device manufacturers need to prepare for, and we’re detailing each below.
These inspections can be “a comprehensive review of the entirety of operations at a facility or can be directed, sometimes referred to as a limited inspection, at a particular issue or issues, such as to ensure compliance with recall actions or to follow up on a corrective action in the facility.”
A manufacturer should expect most instances of these inspections and certainly three of the four we’ll be reviewing here: pre-approval or PMA inspections, routine/mandated inspections, compliance follow-up inspections, and “for cause” inspections. This last one should even come with some forewarning, as you’ll undoubtedly track all of these activities in your Computerized Maintenance Management System (CMMS).
Pre-approval inspections or pre-market approvals (PMA) by the FDA are a requirement for medical manufacturers seeking to bring new products to market. These inspections validate the data submitted in the application and ensure that the manufacturing facility meets the necessary standards for producing the device.
CMMS software plays a vital role in helping medical manufacturers prepare ahead of time for these inspections, ensuring compliance, and expediting the approval process. Here’s what you need to know:
A pre-approval inspection means the manufacturer’s PMA submission meets Quality Management System (QMS) requirements and readiness for inspection. This step is pivotal in determining whether the FDA will recommend either for or against FDA approval based on their findings.
Having access to relevant records and facilitating compliance with regulatory standards, supports efficient approval and market entry for innovative medical products. This makes CMMS software an obvious, and extremely relevant choice.
Routine FDA inspections feel anything but routine when a medical device manufacturer isn’t adequately prepared. Here’s what you need to know to ensure that you are:
It’s important to note that there are two levels of QSIT inspections. Level 2 is a comprehensive Baseline QSIT inspection that covers all four subsystems and typically occurs for the first inspection or every six years thereafter. And a Level 1, sometimes referred to an Abbreviated QSIT, is a shorter inspection that follows a Level 2 inspection and focuses on the CAPA system plus one other major subsystem. Subsequent Level 1 inspections may target different subsystems.
The frequency and type of inspections depend on various factors, including compliance status and any findings from previous inspections. Non-compliance issues or previous 483 observations or warning letters may prompt more frequent inspections.
Staying ahead of and being prepared for these routine inspections requires an organized approach. CMMS software enables medical device manufacturers to prepare proactively for routine inspections with the following capabilities:
Routine inspections will not disappear, so your best bet is to ensure robust documentation and adherence to the quality standards you’ll be measured against.
The FDA conducts compliance follow-up inspections to verify that medical device manufacturers have taken appropriate actions to address significant violations identified during previous inspections. Here’s what you need to know:
After receiving 483 observations or warning letters, the FDA may inspect medical device manufacturers for compliance follow-up. These inspections aim to verify that the company’s corrective actions adequately address the identified violations and ensure compliance with regulatory standards.
During compliance follow-up inspections, FDA inspectors assess whether the manufacturer has responded effectively and implemented and documented appropriate corrective measures. Failure to address previous violations may result in the documentation of additional non-compliance issues, potentially leading to further regulatory action.
Unlike routine inspections, compliance follow-up inspections typically occur without advance notice. This makes it critical for manufacturers to remain vigilant and proactive in addressing any outstanding compliance issues to avoid regulatory repercussions. They can prepare for compliance follow-up inspections by:
CMMS software facilitates preparation for compliance follow-up inspections by:
With a CMMS, medical manufacturers can mitigate compliance risks, uphold industry quality standards, and avoid (or be prepared for) any “for cause” inspections.
“For cause” inspections are unique and can catch medical manufacturers off guard. While they may not occur as frequently as routine inspections, they are prompted by specific issues reported to the FDA, such as consumer complaints, employee concerns, or product recalls. Here’s what you need to know:
“For cause” inspections are typically unannounced and may delve into various aspects of a manufacturer’s operations beyond the initial concern. Unlike routine inspections, there are no established guidelines or protocols for “for cause” inspections. Inspectors have the flexibility to investigate the reported issue thoroughly and may explore other areas of the manufacturer’s operations as deemed necessary.
Medical manufacturers do not receive advance notice of “for cause” inspections, making it essential to maintain a state of readiness at all times—a CMMS is incredibly helpful here. It ensures ongoing compliance and documentation of procedures, processes, and corrective actions. Regular internal audits and management reviews are also important so that you can identify and address potential compliance gaps or issues proactively.
Ensure timely reporting of adverse events, product recalls, or quality concerns to the FDA and implement appropriate corrective actions as needed. And foster a culture of quality and compliance throughout the organization through training, education, and awareness programs.
Prepare for “for cause” inspections by:
Each inspection type detailed here present unique challenges, with “for cause” inspections adding a layer of complexity due to their unpredictable nature and broad scope. CMMS software enhances a medical device manufacturer’s ability to navigate regulatory scrutiny and we’d love to show you a demo of our software in action! Reach out today.