Audits
- Full-scope mock FDA audits to identify compliance gaps before inspection
- Vendor and third-party audits to evaluate supplier quality systems
- Written reports with prioritized findings and actionable recommendations
FORMER FDA NATIONAL DRUG EXPERT
Pharmaceutical Audit Solutions
Capitana Audit Solutions LLC, led by Ileana Barreto-Pettit, helps pharmaceutical companies strengthen GMP compliance, prepare for U.S. FDA inspections, and respond with confidence.
25+Years of Experience
400+Audits Completed
Services
FDA Compliance Services
Inspection Backroom Support
- Real-time support during FDA inspections (onsite or virtual)
- Document requests and SME communications behind the scenes
Remediation
- Review of responses to the FDA
- CAPA Verification
- Preparedness for Follow Up FDA Inspections
Consulting
- Advise on GMP compliance strategies across all stages of operations
- Provide expert insight into FDA expectations and regulatory risk areas
- Offer strategic guidance for global pharmaceutical firms navigating U.S. requirements
Training
- Deliver custom GMP training for QA, manufacturing, and executive teams
- Develop curriculum based on FDA trends and observed deficiencies
REGULATORY EXPERT
Meet Ileana
Internationally recognized regulatory compliance expert and former U.S. FDA National Drug Expert with over 25 years of experience
Contact
Get in Touch
Contact Email
Ileana@CapitanaGMP.comOffice
Miami, FL, USA (Available Globally)