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FDA investigators observed a variety of good manufacturing practice deficiencies during inspections this spring at facilities in California, Minnesota, New York, North Carolina and Texas. Read More
An FDA inspection of Smiths Medical’s Minneapolis facility revealed validation lapses, complaint handling procedures that weren’t handled correctly and inadequate corrective and preventive action (CAPA) procedures. Read More
Quality audits were not being performed at sufficient intervals, and management with executive responsibility had not reviewed the effectiveness of the quality system at defined intervals, the FDA said following an inspection of MedHab’s Arlington, Texas plant. Read More
Inadequate procedures related to medical device reporting and other serious quality issues were uncovered during an April 6-16, 2021 inspection of Forcemech International’s Pearland, Texas facility. Read More
FDA investigators observed a variety of good manufacturing practice deficiencies during four inspections conducted this spring at facilities in New York, California and North Carolina. 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
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
The FDA issued a warning letter to Innova Medical Group in Pasadena, California for false and misleading labeling for its SARS-CoV-2 antigen rapid qualitative test, as well as marketing the test without FDA clearance and a slew of GMP observations at two facilities. Read More
The FDA issued a warning letter to Innova Medical Group in Pasadena, California for false and misleading labeling for its SARS-CoV-2 antigen rapid qualitative test, as well as marketing the test without FDA clearance and a slew of GMP observations at two facilities. 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