Log in or Subscribe Now to 483sOnline.com and get the latest inspection news below and directly to your inbox every week. We track the latest enforcement actions, as well as changes in policy and procedures to keep you in the know!
Failure to validate equipment and to establish CAPA procedures were among the QMS failures discovered during an FDA inspection of contract manufacturer Custom Milling Center’s Golden, Colorado facility. Read More
Lax process validation, inadequate control of nonconforming product and failure to implement CAPA procedures were a few of the concerns the FDA highlighted during an inspection of Mark Two Engineering’s Miami Lakes, Florida facility. Read More