The pump uses a custom battery supplied by AIP upon order from a customer. The batteries were described in the patient manuals to have minimum 6-month longevity. There were a number of calls from patients complaining that their batteries were lasting only about 2 to 3 months. Patients are instructed in the patient manual to always have at least one spare battery.

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 section of the GMP (e.g. CFR820.198, CFR820.70(b), etc.).