Standard Operating Procedure: FDA Inspections

• The United States Food and Drug Administration inspect pharmaceutical companies and device manufacturers to assess if controls, procedures and practices for development and manufacturing of products are in compliance with FDA regulations.
• FDA inspections can have a high impact on a company's business success as well on a company's and individual's reputation.
• This procedure should help make FDA and other inspections successful, which basically means avoiding inspectional observations and warning letters.
• In case deviations are found follow-up procedures should help to minimize damage to a company

Product Scope:

Who will benefit:

• Quality Assurance
• Functional Supervisor (Laboratory/Manufacturing)
• Inspection Team
• Regulatory Affairs
• IT
• Validation Group
• Management