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Documentation for pouch sealing validation conducted by a contract manufacturer lacked a validation protocol, validation activities, raw data, equipment used and a final report. Read More
The FDA cited Houston, Texas devicemaker Talon for a multitude of transgressions at its facility, including problems with validations and complaint investigations. Read More
Phototherapy developer National Biological Corp. fell short on several quality management systems, the FDA said following a Feb. 4-14 inspection of its Beachwood, Ohio plant. Read More
Failure to establish standard operating procedures for investigations landed Singapore-based diagnostics maker MP Biomedicals Asia Pacific in hot water with the FDA following a Dec. 10-12, 2018 inspection of its Singapore facility. Read More
Process validation issues and failure to document complaints and corrective and preventive actions landed devicemaker Duke Empirical an FDA Form 483 following a Dec. 3-21, 2018, inspection of its Santa Cruz, California plant. Read More
Failure to validate the design of its AED batteries, lax complaint handling procedures and numerous other quality system repeat observations resulted in a warning letter for AED maker Zeller Power Products following a Nov. 6-9, 2018 inspection of its Wallace, Idaho facility. The FDA said the firm’s response to the Form 483 was not acceptable. Read More