FDA, FSMA & 21 CFR

General enforcement regulations, records, registration-related requirements, prior notice, importer requirements, traceability-related provisions, and other applicable FDA requirements — including the Foreign Supplier Verification Programs (Subpart L), Sanitary Transportation (Subpart O), and Food Traceability (Subpart S) provisions.

Support for recalls, market withdrawals, corrections, and recall-related regulatory practices — including recall strategy, classification considerations, effectiveness checks, and recordkeeping.

Electronic records and electronic signatures where applicable to FDA-regulated systems, including recordkeeping system reviews and documentation practices that support data integrity.

Food labeling, Nutrition Facts, ingredient statements, allergens, statements of identity, claims, and other food labeling requirements — reviewed against current federal labeling regulations.

Legacy Current Good Manufacturing Practice requirements and historical GMP references, relevant to older programs, facility history, or comparative documentation. Part 110 was superseded by the CGMP requirements now in Part 117 Subpart B — it is not current law, and a program still written against Part 110 is a finding waiting to happen.

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — specification setting at every stage, identity testing of incoming dietary ingredients, master manufacturing and batch production records, and the quality unit that has to sign them off.

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. The written food safety plan, the hazard analysis behind it, and the process, allergen, sanitation and supply-chain preventive controls that follow from it — prepared or overseen by a preventive controls qualified individual.

Hazard Analysis and Critical Control Point Systems for Juice, including the validated process required to achieve the applicable pathogen reduction for the juice concerned, and the distinction between a processor under Part 120 and a retail establishment, which is treated differently.

Hazard Analysis and Critical Control Point Systems for Fish and Fishery Products — one of SURU's most specialized areas. § 123.6(b) requires a plan specific to each processing location and each kind of fish and fishery product, so a generic plan does not satisfy it; § 123.10 requires the plan be developed by an individual trained in accordance with that section; and importers face affirmative-step verification under § 123.12 that operates alongside, and in some cases in place of, FSVP.

Bottled drinking water processing and bottling requirements, where applicable, including source, processing, and quality control considerations.

Food standards and general food provisions where relevant to a product category and its formulation practices.

Standards of identity and standardized food requirements, where applicable to products such as dairy, bakery, seafood, and other standardized categories. A standardized food has to meet its standard before anything else about the label matters.

Food additives and general food safety provisions applicable to ingredient and formulation review.

Food additives permitted for direct addition to food, reviewed as part of formulation and labeling support.

Secondary direct food additives relevant to processing aids and formulation.

Indirect food additives and general provisions relevant to packaging and food-contact materials.

Food-contact substances, adhesives, coatings, paper, polymers, adjuvants, production aids, and related indirect food additive considerations where applicable to packaging and equipment.

Irradiation in the production, processing, and handling of food, where applicable to a process — including the permitted sources, the foods and dose limits involved, and the labeling that follows.

Generally Recognized as Safe (GRAS) substances and direct food substances affirmed as GRAS, reviewed during formulation and ingredient sourcing. A supplier calling an ingredient GRAS is a claim to be substantiated, not a conclusion to be accepted.

Substances prohibited from use in human food, reviewed as part of ingredient and supplier qualification.

Dietary supplement provisions where applicable, including new dietary ingredient notification considerations, reviewed alongside Part 111 CGMP program development.