6. Failure to designate an individual to review for adequacy and approve prior to issuance all documents established to meet the requirements of Part 820 as required by 21 CFR 820.40(a). For example: a) There is no requirement for documenting the signature of the individual approving the document. In your firm’s letter of April 6,...Read More

You failed to evaluate suppliers of components and other materials used to assemble the WatchChildTM device. You had not documented your decisions to use the approved vendors on the approved vendor list. While you have a written procedure for supplier certification and recertification, it was not being followed. The type and extent of control to...Read More