Sabatina & Associates P.C provides professional advice on various regulations of the U.S. government agencies, including the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the National Marine Fisheries Service (NMFS), regarding importing, selling, and manufacturing of foods, dietary supplements, cosmetics, medical devices and drugs in the U.S. market.
Practice Area
Food
- Compliance with FDA regulations from FDA, USDA, NMFS
- Compliance with USDA regulations
- Import Refusal / Import Alert (Red List removal & Green List petition)
- Product Labeling
- Product Development
- Proposition 65 Defense
- FCE-SID Registration
- Voluntary Qualified Importer Program (VQIP)
- Facility and Agent Registration with FDA
- FSMA Hazard Analysis and Risk-Based Preventive Controls
- FSMA FSVP Consultation / Food Safety Plan / Defense Plan / HACCP
- FSPCA PCQI and FSVP Training
Cosmetic
- Compliance with FDA Regulations, including MoCRA
- Establishment Registration / Listing
- Product Labeling / Ingredient Consultation
Medical Devices and Drugs
- Compliance with FDA Regulations
- Establishment Registration / Listing
- OTC Product Consultation