FDA Warns Kelyniam Global for GMPs, Unapproved Products
Devicemaker Kelyniam Global drew a warning letter from the FDA after failing to adequately address numerous GMP issues observed in a May inspection of its Canton, Connecticut facility, including the manufacturing of unapproved implants.
In its response to a Form 483 report issued after the inspection, the firm failed to provide documentation to support its promises to correct the problems, and just said it would create a CAPA for each nonconformance and perform relevant evaluations.
Problems identified in the inspection included a failure to validate several device design changes and to initiate complaint investigations. Other deficiencies were related to device master records, process validation, and procedures for accepting new materials.
