baxter PCA II - Page 67

Specifications
! 6. Reporting Requirements
The following information must be reported:
DATA TIME FRAME ALLOWED TO
OBTAIN INFORMATION
Manufacturer's distribution 3 working days
inventory records
Final distributor's patient and | Reported to the manufacturer promprly
v physician records following distribution to the patient
t . 0000 r > =
Multiple distributor's patient | Upon request, reported co che manufacturer
and physician records within 5 working days
È
Manufacturer's patient records | 10 working days (for multiple patient use
devices such as Infusion Pumps), ie. mul-
S tiple disributor's registries
7. Audit Requirements
; In addition, a statistically relevant sample of the manufacturer's
consignees must be audited every 6 months for che first three years,
then anaually, to ensure compliance with tracking regulations. Cus-
tomers who are not complying wich this regulation must be reported
to the FDA.