We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
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
Allergan failed to comply with post-approval study requirements for its Natrelle silicone-filled breast implants, the FDA said in a warning letter to the Irvine, California-based company. Read More
Not all complaints were assessed to determine whether medical device reports should be filed with the FDA, according to the Form 483 inspection report. Read More
Failure to establish and maintain design validations and proper risk management procedures for its Swaive thermometer landed Taiwan’s E-Care Technology a warning letter From the FDA for inadequate responses to a 483 the firm received following an inspection of its Chubei City facility. Read More