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.
Validation issues, design control and inadequate corrective and preventive procedures were among the quality system failures cited in a warning letter to Wheat Ridge, Colorado-based DeChoker following a Feb. 17-26 FDA inspection. Read More
International Medical Development did not take adequate corrective and preventive actions for quality deficiencies at its Huntsville, Utah, plant, the FDA found in a Feb. 8-12 inspection. Read More
Graphic Controls Data Recording failed to inform the FDA of several complaints about its automatic external defibrillator (AED) pads malfunctioning in a way that could have caused serious injury or death to patients, agency investigators found during an inspection of the company’s Buffalo, N.Y. facility. Read More
The FDA said it plans to gradually resume its on-site drugmaker inspections beginning in July with the intent to be back to normal operations by September. Read More
Graphic Controls Data Recording failed to inform the FDA of several complaints about its automatic external defibrillator (AED) pads malfunctioning in a way that could have caused serious injury or death to patients, agency investigators found during an inspection of the company’s Buffalo, N.Y. facility. Read More
Validation procedures for testing finished devices and software validation procedures related to Koko’s Px pulmonary function testing devices were observed to be inadequate during a Jan. 5-25, 2021 FDA inspection of the firm’s Longmont, Colorado facility. Read More
Failure to adequately validate its purified water system resulted in possible contamination of several lots of Sunstar Americas’ oral hygiene products, the FDA discovered during a Jan. 12 to Feb. 18 inspection of the firm’s Schaumburg, Illinois manufacturing facility. Read More
The FDA said it plans to gradually resume its on-site drugmaker inspections beginning in July with the intent to be back to normal operations by September. Read More
Validation procedures for testing finished devices and software validation procedures related to Koko’s Px pulmonary function testing devices were observed to be inadequate during a Jan. 5-25, 2021 FDA inspection of the firm’s Longmont, Colorado facility. Read More
Failure to adequately validate its purified water system resulted in possible contamination of several lots of Sunstar Americas’ oral hygiene products, the FDA discovered during a Jan. 12 to Feb. 18 inspection of the firm’s Schaumburg, Illinois manufacturing facility. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) resumed in-person inspections on March 29 but it is adopting a hybrid approach that allows for both remote and on-site elements. Read More
The FDA issued a warning letter to Tarmac Products, a Miami Gardens, Florida manufacturer of surgical wound dressings for issues with its medical device quality system. Read More