JAS Diagnostics/Drew Scientific, Inc.

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 adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a). Specifically, you have not adequately implemented your complaint handling procedure titled “*Customer Complaint Handling”, Doc. # EQA 6.2*, in that complaints were not adequately documented, investigated, and evaluated for Medical Device Reportable (MDR) events.

Passage 2

Failure to adequately establish CAPA procedures as required by 21 CFR 820.100(a). Specifically,

Passage 3

Failure to adequately establish a process whose results cannot be fully verified by subsequent inspection and test according to established procedures as required by 21 CFR 820.75(a). Specifically, you have not adequately implemented your process validation procedure, “*Validation Procedure”, Doc # EMF 1.0*. For example,

Passage 4

Failure to establish design control procedures as required by 21 CFR 820.30(a). Specifically, you have not adequately implemented your design control procedure “*Design Controls”, Doc. # ER&D 4.1* in that your firm has not adequately completed implementation of corrections to observations cited during previous inspections associated to Design History File (DHF), design reviews, risk assessment, and shipping validation. For example,

Passage 5

Failure to adequately establish procedures for the control of product that does not conform to specified requirements as required by 21 CFR 820.30(a). Specifically, you have not adequately implemented your non-conforming product procedures. For example,

Passage 6

Failure to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements. Specifically,