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Valeant received a warning letter for a high-precision compounding and dispensing device used to mix two solutions following an inspection that revealed a failure to maintain procedures for validating the device design. Read More
A response to a Form 483 is not a routine or informal communication and should be given the same attention and care you would give to defending your company from a federal indictment — because that’s what a 483 actually is. Read More
PhotoMedex Inc. did not submit medical device reports (MDRs) in a timely manner, conduct an inadequate risk analysis, or establish adequate procedures for design change and corrective action, an FDA investigator reported on a Form 483. Read More
Epimed International Inc. was cited in a Form 483 for inadequate procedures for handling of complaints, design validation, design transfer, control over products, services and suppliers, and accepting incoming products at its Johnstown, N.Y. facility. Read More
Circulatory Technology Inc. received a Form 483 for failing to submit a medical device report (MDR) in a timely manner, properly evaluate an MDR event, establish a design history file, establish adequate design plans and properly investigate complaints. Read More
A high-precision compounding and dispensing device used to mix two solutions together received a warning letter following an inspection that revealed a failure to maintain procedures for validating the device design. Read More
A Colorado device maker has received a Form 483 after investigators witnessed supplier observations and quality system issues. In total six observations were listed. Read More
A response to a Form 483 is not a routine or informal communication and should be given the same attention and care you would give to defending your company from a federal indictment — because that’s what a 483 actually is. Read More