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During the inspection, FDA inspectors will assess compliance with FDA regulations and try to find issues that may affect product quality. The inspection finding can vary with companies and inspectors, but below are common findings to be aware of.
Inadequate documentation is the most common finding. Inspectors will review the document to ensure they are accurate and up to date with regulatory guidelines. Documents related to manufacturing, testing and storage must comply with regulatory standards.
Facility maintenance is another important finding during FDA inspections. Facilities must be well-maintained, including equipment maintenance, cleaning, pest control, and disinfection. Restrooms must be clean and well disinfected.
Job training is also a frequent issue during FDA inspections. Inspectors will review employee training records from all departments to ensure companies’ employees are well-trained for the job they do. All training programs must be documented in training records.
