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A device manufacturer that undergoes an FDA inspection and gets a Form 483 with findings may avert a warning letter from the agency if it “really responds well,” said Jodi Scott, a partner at Hogan Lovells US, speaking Wednesday at the WCG and FDAnews-sponsored FDA Inspections vSummit. Read More
Failure to validate its products or to establish procedures that demonstrate its acupressure bracelets for nausea were manufactured according to specifications were among the 13 quality system lapses observed during a March 29 to April 1 FDA inspection of MumEase’s Charlotte, North Carolina facility. Read More
The pandemic forced the FDA to be far more innovative in its efforts to inspect device and drug manufacturing facilities, and the agency plans to incorporate these new modalities into its site surveillance process going forward. Read More
Devicemaker YFS Pharma did not investigate or keep detailed records of complaints it received about its Lubricity dry mouth sprayer, FDA investigators observed during an inspection of the company’s Buffalo, N.Y., facility. Read More
Managing corrective and preventive action (CAPA) activities is a perennial problem for device manufacturers. Complaints, nonconformances, out-of-specification results all should generate a CAPA file, but the FDA continues to find fault with the way they are handled. Chances are, if you received a 483 at your last inspection, the words “corrective action” appeared prominently on the form. If they did, was your response detailed and specific enough to satisfy the FDA? Read More
Ventec Life Systems failed to send timely medical device reports to the FDA, and its procedures for corrective and preventive actions were not well established, an FDA investigator observed during an inspection of the company’s Bothell, Washington plant. Read More
Failure to file a medical device report within 30 days and to establish adequate procedures for corrective and preventive actions (CAPAs) were among the quality system deviations the FDA discovered during a March 16 to May 4 inspection of Myerson’s Chicago, Illinois facility. Read More
Failure to validate its products or to establish procedures that demonstrate its acupressure bracelets for nausea were manufactured according to specifications were among the 13 quality system lapses observed during a March 29 to April 1 FDA inspection of MumEase’s Charlotte, North Carolina facility. Read More
The FDA has issued a warning letter to a Chinese devicemaker, Tianjin Bolang Science-Technology Development, listing nine violations for ear, nose and throat (ENT) devices exported to the U.S. Read More
The FDA has issued a warning letter to a Chinese devicemaker, Tianjin Bolang Science-Technology Development, listing nine violations for ear, nose and throat (ENT) devices exported to the U.S. Read More
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