FDA EIR - SAFC, Inc. - August 23, 2017

SAFC, Inc. underwent an FDA Establishment Inspection from August 21 to August 23, 2017, at its Madison, Wisconsin facility. This inspection, conducted under Compliance Programs 7382.845 for Medical Device Manufacturers and 7383.001 for Pre and Post Market approval inspections, focused on SAFC's role as a contract manufacturer of a Class III medical device and an active pharmaceutical ingredient (API). The comprehensive review covered management control, corrective and preventive actions, and production and process control subsystems. Notably, this inspection concluded with no FDA Form 483 (Inspectional Observations) issued and no verbal observations discussed, signifying a compliant status at the time of the review. This contrasts with previous inspections; the last medical device inspection in April 2014 resulted in a 3-item FDA 483 concerning equipment maintenance, nonconforming product identification, and CAPA system validation, alongside five verbal observations. A more recent pre-approval inspection in October 2016 also included five verbal observations related to data integrity and process control. The absence of observations in the August 2017 report indicates that SAFC, Inc. successfully met regulatory expectations under the current framework, requiring no immediate corrective actions from this specific inspection. The firm's quality system, including management reviews, internal audits, change control, CAPA, complaint handling, production controls, process validation, incoming inspection, supplier controls, non-conformance procedures, environmental controls, and calibration, were all reviewed without issues.