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FDA inspectors hit Covidien with a Form 483 for inadequate complaint evaluation and process control procedures, as well as failure to ensure appropriate design and installation of manufacturing equipment. Read More
Nomax received a warning letter for failing to evaluate complaints, document corrective and preventive actions, and committing other violations. Read More
Zimmer Biomet’s Warsaw, Ind., medical device facility was hit with a massive, 58-page Form 483 arising from an inspection carried out from September to November of 2016. Read More
Acumedia Manufacturers was cited in a Form 483 for inadequate corrective and preventive action procedures, failing to report a correction or removal, and other violations. Read More
Precision Interconnect was hit with a Form 483 for poor corrective and preventive action (CAPA) procedures and failing to ensure that products conformed to requirements. Read More
The FDA Florida district office issued a Form 483 to Audifon-USA over inadequate procedures for complaint reviews, corrective and preventive actions, and equipment calibration. Read More
White Square Chemical failed to establish a design history file, complete a risk analysis, and committed other violations, according to investigators who handed the company a Form 483. Read More
Acumedia Manufacturers was cited in a Form 483 for inadequate corrective and preventive action (CAPA) procedures, failing to report a correction or removal, and other violations. Read More
Nomax Inc. received a warning letter for failing to evaluate complaints, document corrective and preventive actions, and committing other violations. Read More