FDA Medical Device Inspections: Required Reading

Few things in life are predictable. One event, however, is certain. If your firm manufactures medical devices for sale in the United States, the Food and Drug Administration at some time will inspect your company.An FDA inspection is important. The investigator will evaluate your ability to comply with the regulatory requirements. A negative determination could affect your ability to sell products in the United States. It also could color all of your dealings with the agency as well as your relationship with partner companies and stockholders.