Situation I

In FDA Inspections Situation I conditions are those conditions that provide evidence that there are significant errors in the manufacturers production process leading to defective devices.

Under these conditions inspectors identify system wide deficiencies and are instructed to terminate the routine inspecton and issue an Form FDA 483 list of observations.

Situation I findings are as follows:

• Failure to establish and document a formal quality program
• Failure to validate significant manufacturing processes and quality tests
• Failure to establish and implement adequate record keeping procedures
• Failure to establish and implement adequate failure investigations
• Failure to ensure that finished devices meet all specifications before acceptance

FDA expects firms with Situation I conditions to fully examine their entire manufacturing process. Responses should indicate that the firm is performing a comprehensive assesment of its quality system to identify other problematic areas.