Kabe Labortechnik GmbH
1 extracted findings
FDA source excerpt, selected passage
Failure to adequately establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, your firm does not have a design control procedure that details design input, design output, design verification, design validation, design transfer, design review, and design history, specifically:
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 adequately establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, your firm does not have a design control procedure that details design input, design output, design verification, design validation, design transfer, design review, and design history, specifically:
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.