FDA 483 - Med-Surgical Services Inc., dba CBYON - July 18, 2023

An FDA inspection of Med-Surgical Services Inc., dba CBYON, a medical device manufacturer in Tempe, AZ, revealed two significant quality system deficiencies. The firm failed to conduct required management reviews of its quality system and did not perform internal quality audits as per its own procedures. These observations indicate a lack of fundamental oversight in maintaining an effective quality system.