Sample weekly digest

Week of May 13, 2026

Built from the current local digest file. This sample includes public warning letters and Class I recall signals with source links where available.

Warning letters

Issue date: 2026-05-04

FDA cited CGMP concerns tied to finished pharmaceuticals, including adulterated products and unapproved new drug issues.

CGMPadulterated productsunapproved new drugquality system

Issue date: 2026-05-04

FDA cited CGMP issues related to OTC finished pharmaceuticals, including process validation, laboratory controls, and quality-unit oversight.

CGMPprocess validationlaboratory controlsquality unit

Issue date: 2026-05-06

Class I recall signal tied to pacemaker software maintenance release updates.

Issue date: 2026-05-06

Class I recall signal tied to a BLE communication cyber vulnerability finding.

Issue date: 2026-05-06

Class I recall signal tied to kits that included a recalled glucose monitoring system component.

Issue date: 2026-05-06

Class I recall signal tied to potential Listeria monocytogenes contamination.

Issue date: 2026-04-29

Class I recall signal tied to undeclared hazelnut and soy lecithin allergens.

Issue date: 2026-04-29

Class I recall signal tied to potential Salmonella contamination.

quality systemsCGMP disciplineproduct claims disciplinedevice qualityfood safetyimport controls

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Boundary: Public information only. Educational and informational only. Not legal or regulatory advice. Not affiliated with FDA.