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# Data from First 100 QMSR Inspections Analyzed
- URL: https://www.fdaweb.com/data-from-first-100-qmsr-inspections-analyzed/
- Published: 2026-06-18T12:00:00.000Z
- Updated: 2026-09-14T13:41:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161330

FDA’s release of information from the first 100 medical device inspections conducted under the new Quality Management System Regulation (QMSR) provides a real service for medical device manufacturers that treat QMSR as the inspection model it actually is. That’s the view of independent expert **Marcelo Trevino** writing in a *Med Device Online* [post](https://www.meddeviceonline.com/doc/risk-is-the-spine-what-the-first-qmsr-inspections-reveal-0001?vm%5FtId=2851524&vm%5FnId=100291&user=af07de6f-3851-4b1a-b184-d350b10f9e44&gdpr=0&vm%5Falias=Risk%20Is%20The%20Spine%3A%20What%20The%20First%20100%20QMSR%20Inspections%20Reveal&utm%5Fsource=mkt%5FMDOL&utm%5Fmedium=email&utm%5Fcampaign=MDOL%5F06-18-2026&utm%5Fterm=af07de6f-3851-4b1a-b184-d350b10f9e44&utm%5Fcontent=Risk%20Is%20The%20Spine%3A%20What%20The%20First%20100%20QMSR%20Inspections%20Reveal&mkt%5Ftok=MDc1LU5WQy0wODYAAAGiee5Wb5rxpG5UAlqyHgyyBNr5akUnWIlyQNd1QT%5FrbVksZQGEXRvNtbGAIYj%5Fh6cJ0oCFZ9di-2JYC6jK2hziimGZleBAVUeWLgowWl49Mx1jW2c). Trevino analyzes the five most cited topics on form FDA-483s issued following the QMSR inspections. The issues were:

- risk management;
- outsourcing and purchasing;
- complaint handling and feedback;
- unique device identifier; and
- corrective action.

Tevino says FDA’s messaging for the past year has been signaling the agency’s concern with risk management, and thus it is no surprise that it leads the list of inspection observations. He says FDA has found that company procedures recite ISO 14971 in the abstract but never operationalize it. Further, he writes, risk vocabularies diverge across departments, and risk control measures exist on paper but can’t be executed in the operating reality of the line.

The post describes detailed findings on the remaining four issues and points out where companies have gone astray or missed the impact of the new inspection protocol.

Tevino says the items that are not in the top five issues are also instructive. He notes that design controls, the historical champion of FDA citations, do not appear in the top five but almost certainly reflects the same accounting effect as corrective and preventive action. Also absent from the top five list is management oversight, although the inspection model places significant expectations on it. “What the list captures, more than anything,” Trevino says, “is where risk fails to connect across functions. That is exactly what the new inspection model is designed to find, and the first 100 inspections suggest it is finding it consistently.”