Marian Boardley Consulting LLC
Consultancy preparing standard operating procedures, master manufacturing records and specifications.
- LEAD TIME
- Not publicly disclosed
Overview
Marian Boardley Consulting LLC is an independent dietary supplement regulatory consultancy specializing in 21 CFR Part 111 current good manufacturing practice (cGMP) compliance. Founded in 2008 by Marian Boardley, the firm advises food, drug, and dietary supplement companies on cGMP implementation, conducts compliance audits for manufacturing and labeling, and prepares standard operating procedures, master manufacturing records, and specifications. The firm also maintains a compilation of FDA Form 483 inspection observations organized by 21 CFR Part 111 citation, which has been cited as a data source in independent industry analyses of dietary supplement enforcement trends.
Certifications
No certifications on record.
Capabilities
- PRODUCT TYPES
- 21 CFR Part 111 cGMP Consulting · Compliance Audits · FDA 483 Response Support · SOPs and Master Manufacturing Records · Dietary Ingredient Identity Testing
- CAPABILITIES
- cGMP compliance or quality systems · GMP audits, mock inspections or training · FDA inspection, 483, warning-letter or detention response
Sources
What we couldn't verify
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- Consulting firm, not a manufacturer; single-principal practice
- Strongest for 21 CFR Part 111 cGMP and manufacturing/labeling compliance; not focused on NDI or GRAS pre-market pathways
- Principal's stated prior background is in analytical chemistry and software, not former FDA employment
Dietary supplement manufacturers must comply with 21 CFR Part 111 (cGMP). What Part 111 requires
The connection map between Marian Boardley Consulting LLC and other vendors, capabilities, and certifications is in the manufacturer atlas.
Enforcement screening: included in Inventory Ready's most recent completed pass against FDA's published recall datasets (2026-07-09). Method and limits →
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