Deymed Diagnostic s.r.o.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to establish and maintain adequate design control procedures to control the design of the device in order to ensure that specified requirements are met, as required by 21 CFR 820.30(a)

Passage 2

Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a)

Passage 3

Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). Specifically, your firm has yet to establish procedures for the manufacturing of the various Printed Circuit Board Assembly (PCBA) for the TruScan LT, using the automated pick and place machines (**(b)(4)** and **(b)(4)**).

Passage 4

Failure to establish and maintain adequate procedures to ensure that device history records for each batch, lot or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184.