FDA Regulation

9 10, 2025

FSVP Violations Under Fire: FDA’s 2025 Warning Letters and the Listeria Outbreak Exposing Global Food Supply Chain Risk

By |2025-10-09T15:54:29+00:00October 9th, 2025|FDA Regulated Industries, Food & Beverage Industry, Quality Management, Regulatory Compliance Management, Risk Management|

In 2025, the U.S. Food and Drug Administration (FDA) has continued its crackdow [...]

7 03, 2023

FDA Warning Letters Show Document Management System Issues in Food Industry

By |2024-12-31T23:17:09+00:00March 7th, 2023|Document Management, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Quality Management|

Documentation is a subject that comes up frequently in U.S. Food and Drug Admini [...]

20 04, 2022

Understanding FDA Alignment of ISO 13485 with Quality System Regulation

By |2024-03-04T21:30:05+00:00April 20th, 2022|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]

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