The FDA has unveiled a new compliance program for inspections of combination products. Read More

The FDA hit three device facilities with 483s for quality violations observed during agency inspections. Read More

The FDA sent warning letters to six device companies for violations including missing documents, design validations, and other compliance lapses. Read More

The FDA cited Peerless Injection Molding for lax handling of product complaints at its Garden Grove, Calif., plant. Read More

In vitro diagnostics manufacturer Ramco Laboratories failed to validate all of its Class II IVDs, and it showed a history of lax record keeping, FDA investigators found in an inspection of its Stafford, Texas facility. Read More

ImmersiveTouch failed to validate its software for creating 3D virtual reality models from a patient’s computed tomography and magnetic resonance imaging data, the FDA found in an inspection of the company’s Chicago, Illinois facility. Read More

The FDA issued a warning letter to Klarity Medical Products following an inspection of its facility in Newark, Ohio. Read More

Ideal Implant received a warning letter from the FDA for quality system deficiencies including failure to document complaint investigations and medical device reportability for complaints related to its saline-filled breast implants. Read More