FDAnews Device Daily Bulletin

Unapproved “Custom” Products Land DePuy a Warning Letter

Jan. 27, 2012
The FDA slapped Johnson & Johnson’s DePuy Orthopaedics with a Dec. 8 warning letter for distributing devices without premarket approval. During an inspection of DePuy’s Warsaw, Ind., plant, the company told FDA inspectors the items were sold “under the belief that they were custom devices,” the letter states. Custom devices made for a single physician or dentist are often exempt from premarket requirements if they are not marketed elsewhere.
Devices & Diagnostics Letter