Typical GMP Deficiencies in the Area of Technology in FDA Inspections 2024/2025

FDA inspections from the period 2024/2025 reveal recurring deficiencies in GMP-relevant technical areas. Particularly striking are shortcomings in the maintenance, cleaning and validation/qualification of technical systems. Typical complaints include: Inadequate maintenance and repair of production equipment, e.g. damaged or dirty surfaces, leaking hoses and unresolved defects despite repeated documentation of these defects.

• Inadequate cleaning and disinfection, particularly in aseptic production. For example, equipment was assembled without prior sterilisation, cleaning processes were not validated or were incompletely documented.
• Missing or insufficient smoke studies in critical areas. The air flow did not show a unidirectional flow, which meant that product protection was not guaranteed.
• Omissions in environmental monitoring, such as incomplete monitoring programmes or a lack of  microbiological testing of for exapmple water or air.
• Unqualified process technology, or missing or incomplete process qualifications (PPQ), unsuitable process monitoring or inadequate documentation during equipment qualification.

As shown, technical areas such as equipment qualification, environmental control and cleaning are key inspection points for the FDA.
These deficiencies demonstrate that technical areas with a direct impact on product safety and sterility assurance, such as equipment qualification, environmental control and cleaning, are key inspection points for the FDA.