Compliance & Enforcement
The FDA conducts inspections of medical device manufacturers to ensure they comply with medical device safety and effectiveness regulations. When a medical device manufacturer fails to comply with regulatory requirements, the FDA can take action to enforce compliance using a number of tools. Two such tools used by the FDA are warning letters and recalls. FDA issues warning letters after regulatory violations have been observed. If a recall needs to occur, a company (manufacturer, distributor, or other responsible party) will usually take voluntary corrective action.
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 regulations, including the Quality System regulation. These inspections can result in the issuance of document known as a “483,” which is the form on which the inspector records any observations.
After an inspection, FDA staff reviews any observations captured on the “483” and, if necessary, issues a warning letter.
In the interest of supporting better quality medical devices and communication with industry, the FDA is providing data related to 2010 and 2011 quality system observations and violations. Please follow the links below for information on warning letter citations for 2010 and 2011, as well as inspection observations from 2011.