FDA Compliance Group LLC

Your solution to FDA compliance needs
FDA Compliance Group is located in Denver, Colorado

Audits ~ FDA Consulting Services

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 an FDA regulation, we can perform an audit of your operations.

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

We can audit specific areas of your operation or provide a comprehensive review of your entire system. We'll audit against current FDA regulations and provide gap analysis, including how to correct gaps.

In addition to auditing your plant or facility, we can also perform the following audits on third party facilities, vendors / suppliers, and contract manufacturers and laboratories:

  • GMP audits (Good Manufacturing Practice)
  • Part 58 audits (for non-clinical laboratories)
  • lab SOP audits (Standard Operating Procedures)
  • 21 CFR part 820 audits
  • 21 CFR Parts 210 and 211 audits
  • 21 CFR Part 111 audits
  • QC / QA (Quality Control) audits
  • HACCP audits

Our audits extend to all FDA regulated industries, including:

For more information about audits or to schedule a consultation, please contact us.