Biosensors Interventional Technologies Pte Ltd

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 develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17(a)(1). For example: during the inspection, your firm identified the following two documents as its written MDR procedure.

Passage 2

Failure to submit a report to FDA no later than 30 calendar days after the day your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

Passage 3

Failure to submit a report to FDA no later than 30 calendar days after the day that your firm receives or otherwise become aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it 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).

Passage 4

Failure to establish procedures for corrective and preventive action, as required by 21 CFR 820.100 (a). For example, your firm has not fully implemented Section 6.7 of its procedure for Corrective and Preventive Action, requiring investigation and requiring determination of the "root cause" of the identified quality problem. Specifically,

Passage 5

Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure per 21 CFR 820.75(a). Specifically, the firm's current work instruction for the Spray Coating Machine, WI-10726, a process used to apply the drug coating to the stent of the BioFreedom Drug Coated Stent System devices, does not fully define the specifications **(b)(4)