GxP intelligence, decoded for practitioners.

Medical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators

The Food and Drug Administration (FDA) is classifying the active noise attenuation system for infant incubators into class II (special controls). The special controls that apply to the device type are identified in this order and will be p...

Jul 27, 2026

Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfun...

The Food and Drug Administration (FDA) is classifying the non- medicated topical formulation for treatment of erectile dysfunction into class II (special controls). The special controls that apply to the device type are identified in this...

Jul 27, 2026

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research...

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Evonik Corporation, Filing of Food Additive Petition (Animal Use)

PROPOSED RULEFDA

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Evonik Corporation, proposing that we amend our food additive regulations to provide for the safe use of ethyl cellulose a...

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologic...

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee). This meeting was announced in the Federal Register on June 30, 2026....

Cellular, Tissue, and Gene Therapies Advisory Committee; Amendment of Notice-Biologics License Application (BLA) 125842 From Capricor, Inc....

Francis Esteban Matos: Final Debarment Order

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Francis Esteban Matos for a period of 5 years from importing or offering for import any drug into...

Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool

The Food and Drug Administration (FDA) is classifying the intraoperative surgical angle measurement tool into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of...

Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device

The Food and Drug Administration (FDA) is classifying the diabetes digital behavioral therapeutic device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of...

Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specim...

The Food and Drug Administration (FDA) is classifying the over-the-counter test to detect SARS-CoV-2 from clinical specimens into class II (special controls). The special controls that apply to the device type are identified in this order...

Last updated Jul 27, 2026 · Sources: Federal Register FDA Documents, openFDA Enforcement Reports

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[ FDA ENFORCEMENT INTELLIGENCE ]

Every recall is a quality signal.

Live FDA drug, device & food recalls — food spanning dietary supplements, cosmetics & animal food — mapped to the GxP quality domains SPEQ assesses. Search the record and see where control breaks down across every regulated industry.

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1,000

Recalls tracked (12 mo)

217

Class I (most serious)

167

Drug

515

Device

318

Food / supp. / cosmetic

TOP QUALITY DOMAINS:Environmental Monitoring · 239 Risk Management & CAPA · 163 Documentation & Change Control · 160 Validation & Qualification · 97

[ RESOURCE LIBRARY ]

Guides, alerts, and analysis — built for practitioners.

Every resource maps to a real regulatory requirement and links to the SPEQ template, standard, or tool that helps QA, QC, validation, regulatory, clinical, lab, and manufacturing teams act on it.

PDF · 7 sectionsDownload PDF →

The SPEQ GxP Execution Framework

The canonical practitioner reference for GxP quality execution across regulatory intelligence, delivery methodology, and maturity.

Template · Annex 1 §4Open Template →

Contamination Control Strategy: Implementation Guide

Build a CCS that satisfies EU GMP Annex 1 (2022) §4 — from risk register design to documentation architecture and inspection defense.

Template · Annex 15Open Template →

Validation Master Plan That Survives Inspection

A structured VMP shell with risk-based scope, lifecycle approach, and revalidation triggers aligned to EU GMP Annex 15 and FDA process validation guidance.

Template · USP <1116>Open Template →

Environmental Monitoring Program Design

Design a risk-based EM program per USP <1116> — sampling location justification, alert/action levels, and excursion investigation methodology.

Active · High inspection riskView Standard →

EU GMP Annex 1 (2022) — Mandatory CCS Requirements

The Contamination Control Strategy became mandatory in August 2023. The highest-risk clauses, what inspectors now request on day one, and how to prepare.

Revised Jan 2023View Standard →

ICH Q9(R1) — Updated Quality Risk Management

The 2023 revision adds formality guidance, subjectivity controls, and risk review requirements. What changed and where it now appears in inspections.

Active · High inspection riskView Standard →

FDA Data Integrity & 21 CFR Part 11 Enforcement

Audit-trail completeness and access control remain top 483 citation areas. The Part 11 clauses driving recent findings and how to close the gaps.