Recipient: MRL, Inc..
Product: automatic external defibrillators
We have reviewed your response to FDA-483 Observation # 12 and conclude that the plan was adequate; but without completion of the databases we have no assurance that its implementation will be adequate.
10. Failure to have production and process controls for automated processes, as required by 21 CFR 820.70(i). when computers or automated data processing systems are used as part of production or the quality system . A manufacturer is required to validate computer software for its intended use according to an established protocol. For example, databases that are maintained for data analysis and other tracking and trending functions, including complaint and services access databases, have riot been validated for their intended use.
FDA District: Chicago District Office