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In its first required inspection metrics report for 2017, the FDA found a median time of 35 days between inspection requests by the FDA to device manufacturing facilities and the beginning of inspections, and a median of five days between the beginning of a pre-approval inspection and the issuance of a Form 483. Read More
Inadequate CAPA procedures and failure to investigate failures of the CorTemp ingestible core body temperature sensor devices landed devicemaker HQ a Form 483 following a September 2017 FDA inspection of its Palmetto, Florida facility. Read More
Maico Diagnostics received a Form 483 following an October 2017 inspection for its failure to have a formally designated unit to handle complaints, quality audits and procedures for design review. Read More
The FDA flagged two U.S. facilities and one in Germany for a variety of deficiencies including CAPA failures and investigations of nonconforming products. Read More