https://www.fda.gov/MedicalDevices/ucm230127.htm
Large corporations may have
different complaint handling units for different product types or
different manufacturing establishments. However, there should be only
one formally designated complaint handling unit for each product type
or establishment. If a corporation chooses to operate with different
complaint handling units for products and/or establishments, the
manufacturer must clearly describe and define its corporate complaint
handling procedure to ensure consistency throughout the different
complaint handling units. A system that would allow multiple
interpretations of handling, evaluating, categorizing, investigating,
and following up, would be unacceptable. Each manufacturer should
establish in its procedures which one group or unit is ultimately
responsible for coordinating all complaint handling functions.
http://ip.vialek.ru/category/warning-letters/
На предприятии не установлены надлежащим образом процедуры по получению, рассмотрению и оценке жалоб официально назначенным отделом, как того требует статья 820.198(а) раздела 21 CFR.
https://www.fca.org.uk/publication/thematic-reviews/tr14-18....
Our approach provided valuable insight into how firms manage their complaint functions. This
allowed us to observe any barriers to effective complaint handling.
https://www.fda.gov/iceci/inspections/inspectionguides/ucm11...