Devices from Firms that Have not met Device Quality System Requirements

Why FDA issued it

Note: Revisions of this Import Alert dated 05/10/2021 updated the reason for alert section, guidance section, product description section, and charge section. Changes are bracketed by asterisks (***). Foreign inspection of device manufacturers are being performed and detention without physical examination (DWPE) may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's). Detention Without Physical Examination (DWPE) may be appropriate when an FDA foreign inspection of a device manufacturer has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's). DWPE may also be appropriate when FDA receives information concerning inspections conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement that FDA concludes

Quoted from the “Reason for Alert” section of the FDA page for 89-04, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.