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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
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to resume in-person inspections starting March 29 but it will adopt a hybrid approach that allows for both remote and on-site elements. Read More
“At this time, Team-NB is unfortunately unable to finalize and publish its aligned position on the uniform implementation of such remote audits by notified bodies,” the notified body said. Read More
Failure to control product that did not conform to specifications, and failure to validate software landed contract manufacturer Viant AS&O Holdings in hot water with the FDA following an Oct. 20-23, 2020 inspection at the firm’s Orchard Park, New York facility. Read More