Saturn Orthopedics Gets 483 for Alleged GMP Deficiencies

A lack of written corrective and preventive action procedures and other alleged quality system violations earned Saturn Orthopedics a Form 483 with eight inspectional observations. The form was issued in March after an inspection of the specifications developer’s site in Kansas City, Mo. The company had no written procedures for visual inspection or functional testing of new and refurbished handpieces and osteotomes, which are used for surgery on bones. Acceptance procedures for incoming handpieces and osteotomes were not documented, the form says.
The GMP Letter