You discover that AIP had a problem with loose syringes in the pump that resulted in the initial doses of insulin being delayed in delivery. They had discovered this problem about 6 months ago and had sent some spacers to the patients in the field to correct the situation. These spacers are not documented in the documentation system, and the shipment of these spacers to affected customers is not documented in any shipping documents (i.e. there is no record of that these spacers were ever sent to the field). You feel this may have fallen into the FDA definition of a field correction.

How would you resolve each of the issues within AIP and what kind of notification, if any, would you make to the FDA or the patients? If you feel any of the issues require no further action, justify your decision. If you make any reference to the GMP in your written text, please reference the specific