FDA Facility Inspections – Readiness and Mock FDA Audits

FDA Facility Inspections - Readiness and Mock FDA Audits

To help prepare for FDA facility inspections, PDG device consultants are available to review, improve and implement quality control, quality assurance, document control, and complaint handling procedures.

Improve FDA Facility Inspection Readiness with Mock FDA Audits

We also prepare our clients for FDA inspections by conducting mock audits to include third party facilities such as, vendors, suppliers, laboratories, CROs and CMOs. The resulting gap analyses address QSR, cGMP, Part 11, ICH, ISO 13485, Health Canada (CMDCAS) and European Union (MDD) compliance, among other standards. In addition, our inspections include preparing your team for what to expect during an FDA inspection. This includes often overlooked protocols such as presentation of documents and records, communication, and assignment of efforts to address the various aspects of the inspection. Because the PDG device consulting team is comprised of industry experts with access to former FDA inspectors, we know how to uncover the problem areas that are likely to trigger a 483 or Warning Letter.

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