Home » German Manufacturer Called Out for Validation, CAPA Procedures
German Manufacturer Called Out for Validation, CAPA Procedures
The FDA cited German devicemaker Humanoptics over a deficient CAPA procedure and a failure to validate a color mixing process.
The manufacturer and developer of eye implantation technology was called out for inadequate validation of the mixing process it used in manufacturing silicone colors for its artificial iris product.
In addition, the company’s CAPA procedures lacked requirements for analyzing quality data and using statistical methods to detect frequent quality problems.
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