Failure to establish and maintain design validations and proper risk management procedures for its Swaive thermometer landed Taiwan’s E-Care Technology a warning letter From the FDA for inadequate responses to a 483 the firm received following an inspection of its Chubei City facility. Read More

Devicemaker Lymol Medical FDA received a warning letter from the FDA for failure to validate cleaning and sterilization processes, among other GMP failures, uncovered during an inspection of its Woburn, Massachusetts facility. Read More

The FDA has unveiled a new compliance program for inspections of combination products. 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 hit UK-based devicemaker Bedfont Scientific with a warning letter for quality failures and the handling of data. 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