FDA Regulatory Compliance, 21 CFR 211, Audits, Inspection Prep, Warning Letter Responses, Sterile Drug Manufacturing, Imports, Import Alerts, Training, Label Review, 483 Responses, OTC Monographs, Amount Information Reporting, Detentions, Refusals, Registration and Listing. Erik Slama's consulting qualifications including 13 years as an FDA Investigator, Supervisory Investigator, IPM Import Program Manager and Refusals Manager can be found at www.tinoconsultingllc.com. Remember, If you don't give them an inch they can't take a mile.