Becton, Dickinson, and Company/CareFusion 303, Inc.
5 extracted findings · 3 model-assigned issue types
FDA source excerpt, selected passage
Failure to establish and implement procedures for corrective and preventive actions as required by 21 CFR 820.100(a).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Failure to establish and implement CAPA procedures, with 544 open software defect tickets including 111 catastrophic/severe and incomplete CAPA #8438925.
Supporting FDA text
Source excerpt · automated text-match checkFailure to establish and implement procedures for corrective and preventive actions as required by 21 CFR 820.100(a).
Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, with 8 complaints not evaluated for MDR reporting.
Supporting FDA text
Source excerpt · automated text-match checkFailure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a).
Design validation failed to include adequate risk analysis, ignoring higher severity risks like patient death from delayed medication access.
Supporting FDA text
Source excerpt · automated text-match checkFailure of design validation to include adequate risk analysis as required by 21 CFR 820.30(g).
Failure to submit MDR within 30 days for malfunction likely to cause death or serious injury, as evidenced by late reports for complaints 02840390, 03595420, 02653489, 03500083, 03708861, and 04422892.
Supporting FDA text
Source excerpt · automated text-match checkFailure to submit a report to the FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).
Failure to submit Reports of Correction or Removal within 10 working days for actions that may present a risk to health, including product advisories and software updates.
Supporting FDA text
Source excerpt · automated text-match checkFailure to submit a Report of Correction or Removal, initiated to remedy a violation which may present a risk to health, within 10 working days of initiating such correction or removal, as required by 21 CFR § 806.10.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide results of the management review for the quality metric monitoring timely closure of defects.
- Provide evidence of implementation of corrective actions for CAPA procedures.
- Provide evidence of implementation of corrective actions for complaint handling and MDR procedures, including CAPA 10308384.
- Provide evidence of implementation of corrective actions for risk management and complaint handling, including CAPA 3078666 and CAPA 10315457.
- Complete the retrospective review of complaint records from February 1, 2022 to present and submit newly identified MDRs.
- Submit Reports of Correction or Removal for the actions described in the letter.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.