For medical product manufacturers, the ongoing possibility that an FDA inspection will result in allegations of regulatory violations can be daunting.

Given the immense range of requirements enforced by the agency, it can be difficult to anticipate what FDA investigators may be looking for when they arrive at a manufacturing facility.

Nevertheless, targeting a company’s compliance efforts effectively is critical.

In June 2025, the agency offered medical product manufacturers insights into where they should be focusing their compliance efforts.

The FDA’s Office of Inspections and Investigations identified the top five inspection observations reported by its investigators over the past decade for manufacturers of drugs (in both domestic and foreign manufacturing facilities), biological products, and medical devices.

One of the best ways for medical product manufacturers to be aware of inspection trends and to remain compliant is to stay up to date on the violations that are being alleged by the agency in FDA enforcement letters.

In this white paper, the experts at Thompson FDA present examples of each of the top observations noted by the agency during inspections over the past few years, as reflected in recent FDA enforcement letters. The agency’s enforcement letters are reported weekly to our subscribers and are added to our proprietary searchable FDA Enforcement Letter Database within hours of their release.