After reviewing the customer call logs you identify 1600 calls that AIP has not classified as complaints, but you believe meet the GMP definition for complaints. Included in these are some you believe fall under the Medical Device Reporting (MDR) definition of causing "death or serious injury".

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.).

I need typed answer