Denttio warned by FDA for violating MDR procedures

FDA issued warning letter to Denttio Inc, in which FDA cited 12 violations to regulations. These regulations include but not limited to

1.    Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a).
2.    Failure to establish procedures for corrective and preventive action as required by 21 CFR 820.100(a).
3.    Failure to establish a design history file as required by 21 CFR 820.30(j).
4.    Failure to perform device software validation and risk analysis as required by 21 CFR 820.30(g).
5.    Failure to maintain device master records as required by 21 CFR 820.181.
6.    Failure to establish procedures for finished device and incoming product acceptance as required by 21 CFR 820.80.
7.    Failure to establish Device History Record procedures as required by 21 CFR 820.184.
8.    Failure to adequately establish procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72(a).
9.    Failure of management with executive responsibility to review the suitability and effectiveness of the quality system as required by 21 CFR 820.20(c).
10.    Failure to perform quality audits as required by 21 CFR 820.22.
11.    Failure to adequately establish procedures for training and identify training needs as required by 21 CFR 820.25(b).
12.    Failure to establish document control procedures as required by 21 CFR 820.40 (a).
The warning letter is available on FDA website.
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