FDA Audits and Gap Analysis Consulting

If you'd like to know where you stand with the FDA before the FDA performs an inspection, or if you have an issue with FDA regulations, we can perform an FDA audit of your operations. Our FDA audit services help you identify gaps and create actionable correction plans.

Contact the FDA experts at FDA Compliance Group to schedule your FDA audit or gap analysis consultation today.

Our FDA Audit Expertise

Our team of FDA consultants includes former FDA employees with decades of experience, as well as industry experts and subject matter specialists. By the time we've finished your audit, you'll know exactly where you stand, where you need to be, and how to get there.

FDA Compliance Group can audit specific areas of your operation or provide a comprehensive review of your entire system. We audit against current FDA regulations and deliver gap analysis with practical recommendations for gap correction.

Types of FDA Audits We Perform

In addition to auditing your plant or facility, we perform comprehensive audits on third party facilities, vendors, suppliers, contract manufacturers, and laboratories including:

• GMP audits (Good Manufacturing Practice)
• Part 58 audits (for non-clinical laboratories)
• Lab SOP audits (Standard Operating Procedures)
• 21 CFR Part 820 audits (medical devices)
• 21 CFR Parts 210 and 211 audits (pharmaceuticals)
• 21 CFR Part 111 audits (dietary supplements)
• MoCRA audits (cosmetics)
• QC/QA (Quality Control/Quality Assurance) audits
• HACCP audits
• Labels and labeling audits

FDA-Regulated Industries We Audit

Our FDA audits extend to all FDA regulated industries, including:

• Dietary supplements
• Pharmaceuticals/OTC
• Medical devices
• Cosmetics
• Food & Beverage
• Tobacco
• Clinical trials

Benefits of Our FDA Audit Services

Our FDA gap analysis and audit consulting services provide:

• Clear compliance status so you know exactly where you stand with FDA requirements
• rioritized gap analysis to understand which issues need immediate attention
• Practical correction plans which give your company or brand actionable steps to achieve and maintain compliance
• Third-party risk management including audits of vendors, suppliers, and contract manufacturers
• FDA inspection readiness preparation that reduces Form 483 observations

Get Started With Your FDA Audit

Ready to assess your FDA compliance status, identify gaps, and prepare for inspections?

Contact the experts at FDA Compliance Group today to discuss your FDA audit services, gap analysis needs, or inspection preparation requirements