FDA Inspection Consulting

FDA inspection consulting encompasses the preparation of manufacturing facilities entering the inspection of the American Food and Drug Administration (FDA) in terms of facility, process, and quality system. Envora Global assesses the existing system, implements an improvement plan, and prepares your team for the inspection.

Scope of FDA Inspection Consulting

• Assessment of the existing system: examination of the facility, equipment, process, and documentation according to FDA expectations.
• Renovation and facility improvements: production areas, microbiology laboratory, DI water, HVAC, and clean room applications.
• GMP practices, training, and documentation: strengthening the quality system.
• Preparation for inspection: pre-inspection checks and team readiness.

Our FDA Experience

In the DELTA Cosmetics (Istanbul) project, GMP consulting for FDA inspection, existing system assessment, and renovation work are ongoing. GMP and FDA consulting for SAFIR Salt’s salt production facility in Kırıkkale, which meets pharmaceutical standards, and FDA inspection preparation for TALYA Herbal’s production and R&D center in Antalya are included. FDA inspection preparation has also been conducted for the Sandoz Pharmaceuticals generic drug factory project in Gebze.

Who Is It For?

It is suitable for manufacturers supplying or planning to supply raw materials that meet pharmaceutical standards for drugs, cosmetics, or dietary supplements to the US market. The work plan is created according to your product group and the current status of your facility.

Our FDA Inspection Preparation Process

The first step in preparing for an FDA inspection is to evaluate the existing system with an impartial perspective. The facility, equipment, production processes, laboratory applications, and documentation are examined to identify risky areas. Improvements are then prioritized; if necessary, facility renovations, infrastructure adjustments, and updates to the quality system are planned.

During the implementation process, your team receives GMP training, and documentation is updated. In the final phase, pre-inspection checks confirm the facility and team’s readiness. This approach aims to reduce the risk of surprises on inspection day.

Why Envora Global?

FDA inspections question both the facility infrastructure and quality culture. Envora Global’s engineering team and quality system approach allow us to address these two dimensions together. Our ongoing FDA projects in the fields of cosmetics, pharmaceutical-grade raw materials, and dietary supplements demonstrate our familiarity with the requirements across different product groups.

Key Areas in FDA Inspections

In FDA inspections, production processes, laboratory applications, water systems, ventilation and clean room conditions, and the documentation of all these processes are examined together. Inspectors pay particular attention to whether the records are consistent with field applications and whether the quality system is continually functioning. Therefore, the preparation work should not be limited to updating documents; the facility infrastructure, equipment, and personnel practices should also be addressed with the same diligence.

In the DELTA Cosmetics project, production processes and the microbiology laboratory, as well as DI water, HVAC, and clean room applications are part of the preparation. In the SAFIR Salt project, GMP filling and packaging areas, and quality control and microbiology laboratories are included in the preparation.

We work alongside your team at every step of the preparation process, transparently sharing findings with you and ensuring the sustainability of improvements.

All project planning and implementations are conducted in accordance with GMP (Good Manufacturing Practices) regulations, ISO and HACCP standards, and the requirements of the Ministry of Health / Ministry of Agriculture and Forestry.

Our Process in FDA Inspection Consulting Projects

1. Concept design: determining product groups, capacity targets, material and personnel flows.
2. Project design: GMP layout plan, HVAC – clean room, DI water and other infrastructure systems design.
3. Installation and implementation: clean room partition and panel systems, selection and installation of production machinery.
4. Qualification and validation: verification of equipment, systems, and processes, commissioning.
5. Quality system and preparation for inspection: documentation, training of key personnel, and preparation for official inspections.

Our Reference Projects

• DELTA Cosmetics FDA and GMP Consulting – DELTA Cosmetics, Istanbul (2021-2026): existing system assessment and renovation; GMP consulting for FDA inspection.
• SAFIR Salt Pharma Grade Salt Production Facility – SAFIR Salt, Kırıkkale (2023-2026): salt production and packaging areas meeting pharmaceutical standards; GMP filling and packaging area.
• TALYA Herbal Production and R&D Center – TALYA Herbal, Antalya (2024-2026): dietary supplement and cosmetic production and R&D center; project design, installation, training, and quality system documentation.
• Sandoz Pharmaceuticals Gebze Generic Drug Factory – Sandoz Pharmaceuticals, Kocaeli / Gebze (2006-2009): improvement of GMP practices; EU-GMP documentation system.

Let’s Plan Your Project Together

Contact Envora Global to assess your needs for your FDA inspection consulting project and to collaboratively create your roadmap.