In a recent FDA inspection, a medical device manufacturer was cited for failure to conduct internal audits of their order processing systems, and contract review procedures. These two areas are ordinarily outside the purview of a typical FDA inspection.
The 483 reads as follows:
Specifically, your procedure, SOP…, Internal Auditing Procedure, states that internal audits are to be completed per the internal audit schedule and that documentation of the internal audit should be maintained. However, there is no documentation for the internal audits of the Order Processing, Contract Review, Customer Complaints, Reporting to Regulatory, and CAPA processes that were to be completed per your Internal Audit Schedule approved for …
FDA does not usually review the results of an internal audit. They do look to confirm that all stated parameters in the audit SOP are covered. For instance, “order processing and contract review” are not necessarily systems covered by a GMP audit. However, if the audit protocol suggests these systems should be covered in an audit, then FDA will expect that to be the case. The old mantra “Do what you Say, and Say what you Do” applies here.
Each audit must result in a report that includes the dates and results of the audits and any reaudits. These reports contain valuable information that should be reviewed by the quality and management teams. A simple coverpage that states the date of completion and areas covered is normally sufficient to demonstrate to an inspector that the audit took place in conformance with the SOP. This 483 observation is an “unforced error” by the quality team.
As per 21 CFR 820.3 Quality audit means a systematic, independent examination of a manufacturer’s quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.
