Data Integrity: The Foundation of Medical Product Manufacturing Compliance

The FDA and other global regulators rely on reviews of data during inspections to determine whether a pharmaceutical or medical device manufacturer is operating within regulatory requirements and expectations. The credibility of that data is a crucial parameter in the regulator’s assessment of whether... Read more

Writing: The FDA Compliance Problem No-One Talks About

There are no FDA regulations governing writing quality or clarity. FDA Investigators will never note “poor writing” as a 483 observation or warning letter citation. But when it comes to regulated manufacturing operations, the FDA’s rule of thumb is... Read more

New DRAFT FDA Guidance Published Today – Nonbinding Feedback

Important DRAFT FDA Guidance issued today (dated 2/19/19 however) regarding "non-binding feedback" after FDA inspections of certain medical device establishments. Limited to statutory (FDARA 704) situations involving a "public health priority", "implicat[ion] of systemic or major actions" or... Read more


Two months ago I posted in LinkedIn about a Popular Science article that unfairly characterized FDA’s regulatory process, and implied FDA tacitly agreed with a company’s characterization of what can best be considered a sham product as a... Read more