Inspections with a Postmarket Surveillance Focus

By Billy Delfs

Complaint reviews during inspections are intense. To the manufacturer, these reviews feel like unfair hindsight, but to the Agency, they advance the FDA mission to protect and promote public health. As a quality system element, complaint handling helps identify trends, detects potential violations of FDA regulations, and provides feedback loops with the company’s CAPA system.

The FDA conducted 4,400 device inspections from October 2023 through September 2025. Of those, 38 percent were classified as postmarket surveillance activities. This mirrors the proportion of time FDA investigators typically spend reviewing complaint files during a for-cause inspection.

Complaint Process Inspection Threads Beyond CAPA: Supplier Quality

A September 2025 Warning Letter to the Philips Ultrasound and Philips Medical Systems Nederland B.V. divisions of Royal Philips contained more than 100 references to the term “complaint.” The Warning Letter resulted from three inspections: two at U.S. facilities and one simultaneously at Philips Medical Systems headquarters in the Netherlands.

Observation 1 detailed supplier quality compliance gaps related to complaint and adverse event/MDR processes. The Ultrasound and Medical Systems divisions were found in violation of 21 CFR 820.50 – Purchasing Controls. The divisions had contracted those processes to a centralized department within the parent company, but common corporate ownership was not sufficient to demonstrate compliance. The violations cited the company’s failure to follow supplier management requirements for complaint handling and adverse event reporting processes. This highlights the high-risk classification of these processes, which allow for no exceptions or exemptions, including internal transfers of responsibilities.

Regulatory Requirements

Under 21 CFR 820.198, medical device manufacturers must document, evaluate, and investigate complaints while simultaneously assessing them for reportability under the Medical Device Reporting (MDR) regulation, 21 CFR 803.

Observation 6b of the same Philips Warning Letter illustrates FDA’s requirements for linking MDR and complaint processes to other quality systems. The first link requires a documented risk assessment within the complaint. The second link is the analysis of complaint data as an input to risk management activities to drive design and process decisions for acceptable risk/benefit ratios.

No MDR Exception for Near-Misses

The Warning Letter issued to Insung Medical Co. Ltd. on September 30, 2025, provides a detailed example of the Agency’s expectations for implementing the MDR regulation. Insung Medical Co. Ltd. manufactures endobronchial tubes used to ventilate one lung during thoracic surgeries and other critical care scenarios.

One violation involved the failure to report a malfunction that occurred during a pre-use check. Insung had logged the complaint but did not submit an MDR. The letter stated: “Generally, a malfunction is reportable if, among other factors, the malfunction involves a device that is considered to be life‐supporting or life‐sustaining and thus is essential to maintaining human life. See Medical Devices; Medical User Facility and Manufacturing Reporting, Certification and Registration; Final Rule, 60 Fed. Reg. 63578, 63585 (Dec. 11, 1995). The fact that the malfunction occurred once leads to the presumption that the malfunction will recur.”

Compliance Chain Reactions

Warning Letters often reflect a cascade of missed opportunities to solve compliance problems. One example was the 2023 Warning Letter to Abiomed, Inc., a subsidiary of Johnson & Johnson MedTech and the maker of the Impella family of Class III devices.

The Warning Letter traced several complaints through their full sequence of receipt, classification, reportability, investigation, CAPA, HHE, and recall decisions. The Agency first cited Abiomed for failing to submit an MDR and then for submitting late MDRs during the inspection. This shows how multiple observations can stem from one set of data.

Recommendations

Manufacturers can strengthen inspection readiness by implementing practical, repeatable processes that align complaint handling with FDA expectations. The following recommendations provide concrete steps that support consistent documentation, clearer risk signaling, and more reliable postmarket oversight

• Internal complaint-handling audits annually with focus on MDR linkages and CAPA integration
• Risk assessments documented within complaint files
• Supplier management procedures that account for internal departments as suppliers when functions are centralized
• Treat near-miss malfunctions for life-supporting devices as MDR-reportable
• Trend analysis on complaint data to surface latent risks

How Gardner Law Can Help

Proactive, independent reviews can identify compliance gaps before regulators do. Agency reviews of complaints and adverse event reports continue beyond the close of an inspection, and having a quality system free of silos is a regulation, not an expectation.

“The trend toward postmarket surveillance inspections underscores the FDA’s expectation that manufacturers integrate complaint, MDR, and risk-management processes into a unified system, not operate them in silos,” says Billy Delfs, Associate Attorney at Gardner Law. “Companies that recognize this shift early turn compliance into a strategic advantage rather than a corrective exercise.”

Pre-inspection reviews of complaint files will often reveal compliance gaps and trends that company experts overlook because of routine operational biases. Our team can identify trends and missed MDR filings to help mitigate the consequences of Agency observations through proactive resolutions.

Contact us to schedule a risk management readiness review or a tailored training session. Turn compliance into a competitive advantage.