Becton, Dickinson, and Company/CareFusion 303, 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 establish and implement procedures for corrective and preventive actions as required by 21 CFR 820.100(a).

Passage 2

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

Passage 3

Failure of design validation to include adequate risk analysis as required by 21 CFR 820.30(g).

Passage 4

Failure 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). For example:

Passage 5

Failure 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. For example: