Compliance & Enforcement
The FDA conducts inspections of medical device manufacturers to check that they are complying with medical device regulatory requirements. When a medical device manufacturer fails to comply with these requirements, the FDA responds with tools that include warning letters and recalls. In most cases, a company (manufacturer, distributor, or other responsible party) will take voluntary action to correct the violations identified by the FDA.
The CDRH Inspections Database provides information about FDA medical device inspections from 2008 to the present. The database contains information about the firms, types of devices and inspections, and links to warning letters (when available).
Each year, the FDA conducts inspections of medical device manufacturers to assess compliance with regulatory requirements, including the Quality System regulation. These inspections can result in the issuance of document known as a “Form 483,” named for the form on which the investigator records any observations.
After an inspection, FDA staff reviews the Form 483 and decides whether agency action is needed to assure correction of the cited violations.
In the interest of supporting better quality medical devices and communication with industry, the FDA is providing data related to 2010, 2011, and 2012 quality system observations. Please follow the links below for information on warning letter citations for these years, as well as inspection observations from 2011 and 2012.
Compliance and Enforcement Actions
Quality System Data
• FDA Medical Device 2012 Quality System Data – Analysis of 2012 Inspection Observations and Warning Letter Cites(PDF - 160KB) FDA Medical Device 2011 Quality System Data – Analysis of 2011 Inspection Observations and Warning Letter Cites(PDF - 171KB)
- FDA Medical Device 2010 Quality System Data - Analysis of 2010 Warning Letter Cites (PDF - 117KB)