A company recently received this 483 observation:
…..Risk analysis is inadequate and is incomplete.
Specifically, the ….. risk assessment documents have not been updated to include the hazards and estimation of occurrence and severity of patient harm due to adverse events. Procedure Risk Assessment and Control defines the requirements for performing product risk analysis, risk evaluation and risk control, which includes identification of the intended use; assessment of characteristics that have the potential to impact the safety of the product/system; identification of all known and foreseeable hazards in both normal and fault conditions, considering intended use as well as reasonably foreseeable misuses; estimation of the potential consequences of hazardous situations (severity of harm) and the likelihood of the occurrence of harm. Still, this procedure was not implemented for the information collected by your firm regarding the ….. adverse events.
For more observations pertaining to device manufacturing controls see Issue 1026available today. It also has observations pertaining to manufacturing controls, laboratory controls and sterile manufacturing controls.
We also have 2 additional reports available today. A special report on observations pertaining to Building and Facilities and the Drug and Device Facility Inspection List from 4/2019 – 6/2019.
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