Future Diagnostics Solutions B.V.

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 verify or validate corrective and preventive actions (CAPA) to ensure that such actions are effective and do not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).

Passage 2

Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, including, the identification, documentation, evaluation, segregation, and disposition of nonconforming product, and to ensure that the evaluation includes a determination of the need for an investigation, as required by 21 CFR 820.90(a).

Passage 3

Failure to establish and maintain procedures for identifying valid statistical techniques and to ensure that sampling plans are adequate for their intended use, as required by 21 CFR 820.250.

Passage 4

Failure to adequately establish procedures for quality audits and conduct such audits to ensure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.

Passage 5

Failure to adequately develop, maintain, and implement written Medical Device Reporting (MDR) procedures as required by 21 CFR 803.17(a). For example, during the inspection, your firm identified the document titled “SOP Medical Device Reporting,” SOP-087, Rev. 14, dated 11/7/2022, as its MDR procedure. After reviewing the procedure, the following deficiencies were noted:

Passage 6

Failure to submit a report to 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 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).