- Regulatory compliance services prerequisite requirements described by Title 21 Code of Federal Regulations.
- Regulatory Services includes but are not limited to, assisting with regulatory issues, label and material reviews, FDA registrations, premarket review, warning letter responses, product development strategy, FDA and USDA compliance, Quality Assurance and Quality Control Preparation, and Post Market Compliance.
- Records – made available for FDA and USDA.
- Food Labeling – Requirements, Statements, Nutrition, Claims, and Identity.
- cGMPs – Prevention of adulteration by workers, facility, equipment and utensils, ingredients, containers, closures, manufacturing, microorganisms, packaging, labeling, controls of release, and traceability.
- Production and Process Controls – QC Operation, Specifications, Sampling, Testing, Material Review, Reprocessing and Deviation Controls, Packaging, Receiving, Rejecting, Manufacturing Operation, Batching, Laboratory Controls, Methodology, Warehousing and Distribution.
- Sanitation Controls.
- Holding and Distribution – Reprocessing, Reworking, and Rejecting, Product Complaints Investigation and Review.
- Personnel – Health and Hygiene, Qualification, Supervisory Requirements, and Training
- Quality Factors.
- Registration, Submission, and Notification Requirements.
- Building and Facilities – Designs, Construction, and Controls.
- Equipment and Utensils Requirements.
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