Unilam Co., LTD
6 extracted findings
FDA source excerpt, selected passage
Failure to establish, implement, and maintain one or more processes for risk management in product realization, as required by ISO 13485:2016 Clause 7.1.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Failure to establish, implement, and maintain one or more processes for risk management in product realization, as required by ISO 13485:2016 Clause 7.1.
Source passage selected by the model
02
Failure to adequately document design and development procedures, as required by ISO 13485:2016 Clause 7.3.1.
Source passage selected by the model
03
Failure to adequately establish criteria for the evaluation and selection of suppliers, as required by ISO 13485:2016 Clause 7.4.1.
Source passage selected by the model
04
Failure to maintain written agreements requiring suppliers to notify the firm of changes to purchased product prior to implementation, as required by ISO 13485:2016 Clause 7.4.2.
Source passage selected by the model
05
Failure to adequately document procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner consistent with monitoring and measurement requirements, as required by ISO 13485:2016 Clause 7.6.
Source passage selected by the model
06
Failure to monitor and measure the characteristics of the product to verify that product requirements have been met, as required by ISO 13485:2016 Clause 8.2.6.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.
21 CFR 101021 CFR 100021 CFR 1040.20(f)21 CFR 1010.221 CFR 1002ISO 13485 7.1ISO 13485 7.3.1ISO 13485 7.4.1ISO 13485 7.4.2ISO 13485 7.6ISO 13485 8.2.6