Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to perform rework in accordance with documented procedures that take into account the potential adverse effect of the rework on the product, as required by ISO 13485:2016, Clause 8.3.4.
Passage 2Failure to document one or more processes for risk management in product realization, as required by ISO 13485:2016, Clause 7.1.
Passage 3Failure to document corrective action procedures to define the requirements for determining the causes of nonconformities and reviewing the effectiveness of corrective action taken, as required by ISO 13485: 2016: Clause 8.5.2.
Passage 4Failure to document the requirements for the work environment and the procedures to monitor and control the work environment, when conditions for the work environment can have an adverse effect on product quality, as required by ISO 13485:2016, Clause 6.4.1.
Passage 5Failure to document procedures for the validation of the application of computer software used for the monitoring and measurement of requirements, as required by ISO 13485:2016, Clause 7.6