Purchasing Control Citations Rose 19% in FY2025

What the FDA’s inspection records show about supplier oversight and what they cannot yet show about the QMSR.

Purchasing controls (21 CFR 820.50) drew 190 citations on device Form 483s in FY2025, up from 160 in FY2024. The rise is 19%. Of the sections that drew at least 50 citations in FY2024, three grew faster: personnel at 27%, process validation at 23%, and document controls at 23%. All device citations together rose 12%, from 2,383 to 2,660.

FY2025 covers inspections that ended between October 1, 2024 and September 30, 2025. Every one of them ran under the Quality System Regulation. The QMSR took effect on February 2, 2026, so these records cannot show how companies are responding to it. The first fiscal year that can is FY2026.

The spreadsheets do not explain the rise. The spreadsheets show more forms and more citations: 791 Form 483s in FY2025 against 672 in FY2024. The FDA says the spreadsheets “are not a comprehensive listing of all inspectional observations,” so the real totals are higher.

A Form 483 is not a warning letter. The FDA posted 54 device warning letters issued in FY2025, and 45 of them allege a quality-system violation. Vellum counted the sections each letter cites. Across the 99 such letters issued from October 2023 through September 2026, 36 cite purchasing controls.

The letters name specific gaps. In its September 22, 2026 letter to Unilam Co., LTD, the FDA cited procedures that set no criteria for evaluating and selecting suppliers. The firm also had no written agreements requiring its raw material suppliers to notify it of changes. The FDA judged the firm’s fixes for both not adequate.

If a key supplier changed a process tomorrow, what in writing would require it to tell you first?

Sources: the FDA’s inspection observations spreadsheets for FY2024 and FY2025 (Devices), and the FDA’s warning letter to Unilam Co., LTD, CMS #738562.