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).
1. Pre-approval or PMA Inspections
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:
- Pre-approval inspections are conducted by the FDA to verify the accuracy of the data presented in the product application and to assess the suitability of the manufacturing facility for producing the device. The FDA employs a risk-based approach to determine which facilities require inspections, considering factors such as product, facility, and process risks and typically give five days’ advance notice of a pre-approval inspection.
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.
2. Routine or Mandated FDA Inspections
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:
- Mandated Inspections: Medical device manufacturers of Class II or Class III devices are subject to routine inspections every two years as mandated by law. These inspections may be conducted with a five-day advance notice or could occur unannounced.
- Purpose of Routine Inspections: The primary objective of routine inspections is to assess compliance with regulatory requirements using the Quality System Inspection Technique (QSIT). Inspectors systematically evaluate four major subsystems of the quality system: corrective and preventive actions (CAPA), design controls, management controls, and production and process controls.
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:
- Maintaining comprehensive records of maintenance activities, including CAPA and production processes.
- Facilitating real-time monitoring and tracking of the corrective actions and preventive measures taken to address any compliance issues.
- Generating reports and documentation required for demonstrating compliance with regulatory standards.
- Providing access to historical inspection data and trends to identify areas for improvement and mitigate compliance risks.
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.
3. Compliance Follow-up Inspections
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:
- Promptly addressing significant 483 observations or warning letters issued by the FDA.
- Implementing corrective actions and preventive measures to rectify identified violations and prevent recurrence.
- Maintaining thorough documentation of corrective actions taken, including timelines and outcomes, to demonstrate compliance during inspections.
- Conducting internal audits and assessments to identify and address potential compliance gaps proactively.
CMMS software facilitates preparation for compliance follow-up inspections by:
- Centralizing documentation of corrective actions, including 483 observations and warning letters, for easy access and reference.
- Tracking the status and progress of corrective actions in real-time to ensure timely resolution of compliance issues.
- Generating reports and documentation required for demonstrating compliance with FDA regulations.
- Facilitating collaboration and communication among stakeholders involved in the corrective action process to streamline compliance efforts.
With a CMMS, medical manufacturers can mitigate compliance risks, uphold industry quality standards, and avoid (or be prepared for) any “for cause” inspections.
4. “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:
- Centralizing documentation of adverse eventsand corrective actions for easy access and reference during inspections.
- Providing real-time tracking and monitoring of compliance status and corrective action progress to ensure readiness for regulatory scrutiny.
- Facilitating prompt communication and collaboration among stakeholders involved in addressing reported issues and implementing corrective measures.
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.
