The FDA issued a Form 483 to Vital Connections, citing the medical device manufacturer on process and design validation procedures.
The FDA issued the form after a March 2018 inspection of the firm’s Tipp City, Ohio, facility. Investigators found the facility did not maintain process validation procedures and had not conducted validation activities for any of its production processes, including mold press operations used to manufacture plastic connectors and snaps.
Investigators found the company’s design control validation procedure did not ensure that the validation followed pre-established protocols. In July 2015, the company sent product not yet available for sale to several local hospitals without developing a protocol to ensure that design validation activities were adequately completed or setting parameters to be tested.
The company also failed to ensure all specifications were met, with three assembly processes reviewed during the inspection failing to meet the established setting.
The agency also faulted the company on its corrective and preventive action procedures, noting that the company standard operating procedures for CAPAs did not ensure problems were adequately handled.
The FDA also hit the firm on its document control procedures. Its SOPs did not properly ensure all documents used in the manufacturing areas are controlled. On one occasion, investigators observed a Post-It Note with handwritten manufacturing steps attached to a printed procedure.