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Inadequate procedures for managing corrective and preventive actions and for monitoring and controlling process parameters landed DJ Orthopedics a form 483 following an FDA inspection of its Tijuana, Mexico facility. Read More
Perahealth didn’t have any design plans for its PeraTrend and PeraServer software used in monitoring patients, and it lacked appropriate documentation for numerous quality system processes, according to a Form 483 the firm received following an FDA inspection of its Charlotte, North Carolina facility. Read More
Failure to file medical device reports with the FDA within the prescribed 30-day period after becoming aware that its glucose meter may have contributed to an injury landed South Korea’s Philosys a warning letter. Read More
Failure to document corrective and preventive action (CAPA) activities related to its x-ray equipment landed Deerfied Imaging a Form 483 from the FDA following an inspection of its Minnetonka, Minnesota facility. Read More
Inadequate procedures for managing corrective and preventive actions and for monitoring and controlling process parameters landed DJ Orthopedics a form 483 following an FDA inspection of its Tijuana, Mexico facility. Read More
Perahealth didn’t have any design plans for its PeraTrend and PeraServer software used in monitoring patients, and it lacked appropriate documentation for numerous quality system processes, according to a Form 483 the firm received following an FDA inspection of its Charlotte, North Carolina facility. Read More
Failure to file medical device reports with the FDA within the prescribed 30-day period after becoming aware that its glucose meter may have contributed to an injury landed South Korea’s Philosys a warning letter. Read More
The FDA cited six U.S. devicemakers for a variety to quality failures including failing to submit medical device reports or to maintain a device master record. Read More
Failure to control nonconforming products landed Dongguan Microview Medical a warning letter following an FDA inspection of its facility in Guangdong, China. Read More
The FDA slapped Thai condom manufacturer Okamoto Rubber Products with a warning letter after receiving an inadequate response to a 483 following an inspection of the firm’s Pathumthani site. Read More