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# Device Inspections Show Tougher Enforcement: Law Firm
- URL: https://www.fdaweb.com/device-inspections-show-tougher-enforcement-law-firm/
- Published: 2025-09-19T12:00:00.000Z
- Updated: 2026-09-14T15:22:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159904

FDA appears to be escalating medical device oversight this year, issuing more Warning Letters and relying on artificial intelligence to zero-in on compliance gaps, according to a [new analysis](https://www.jdsupra.com/legalnews/fda-medical-device-inspections-in-2025-3088083/?ref=fdaweb.com) from law firm Hogan Lovells.

As of early September, the agency had issued 19 Warning Letters citing Quality System Regulation violations — up from 12 during the same period last year, the law firm notes. The agency also issued eight letters tied to investigational device exemptions and bioresearch monitoring, compared with seven in 2024\. They say the surge likely reflects pressure on the agency to demonstrate vigilance amid ongoing scrutiny of device safety and clinical trial integrity.

Unlike in past years, Hogan Lovells says FDA is using Warning Letters not just as corrective tools, but as part of a broader strategy to ensure year-round compliance. Many recent letters have included commitments to follow-up inspections, signaling sustained oversight. “Moreover, FDA is providing feedback to Form 483 responses in untitled letters,” it says. “We have observed several untitled letters being issued even when the agency has not identified any Form 483 responses that were deemed to be inadequate.”

Hogan Lovells noted that field investigators are taking a harder line, citing issues such as document formatting, complaint file organization, and incomplete corrective and preventive actions (CAPAs) — areas once considered low enforcement priorities. In some cases, problems traced to postmarket complaints have been linked back to flaws in device design inputs, leading to cascading citations across design controls, CAPAs, and risk management, it says.

The agency is also leaning on AI systems such as ELSA to analyze complaint data, adverse event reports, and past inspection results, the analysis shows. The technology is being used to flag high-risk facilities and identify companies with unresolved compliance problems. According to the analysis, FDA’s top inspection focus areas this year include:

- CAPAs: deficiencies in root cause analysis, documentation, and follow-through.
- Design controls: discrepancies between cleared 510(k) submissions and marketed devices.
- Complaint handling: incomplete investigations and failures to link complaints to CAPAs or recalls.
- Purchasing controls: weak oversight of suppliers and contract manufacturers.
- Labeling and unique device identification (UDI): gaps in traceability and data consistency.

The agency has also cracked down on companies that fail to integrate newly acquired products or businesses, often citing deficiencies tied to legacy documentation and oversight. Contract manufacturer oversight has also emerged as another recurring weakness, with FDA holding sponsors accountable for lapses at third-party facilities.

“FDA is not just modernizing — it’s intensifying,” the firm writes, noting that inspectors are “asking tougher questions, demanding deeper documentation, and expecting systems that demonstrate real-world effectiveness.”