Supplement Brand Owner Compliance Pack (21 CFR 111)
39 procedures, forms and lists for companies that sell dietary supplements under their own label and have them made by a contract manufacturer. It covers the 21 CFR Part 111 and FD&C Act duties that stay with the brand owner.
If your name is on the label, FDA holds you responsible for the product, even when someone else makes it. FDA has issued warning letters to own-label distributors who had no specifications, no batch review and no quality agreement with their manufacturer.
This pack gives a brand owner exactly what it needs to show control:
Dietary Supplement Quality Agreement (FORM 0124-DS) and Brand Owner Responsibilities Matrix (LIST 0003-DS): who does what for each Part 111 activity, with change notification, adverse event forwarding and audit rights.
Contract manufacturer qualification (SOP 7-109-DS) and supplier management, with the supplier audit checklist and self-assessment.
Specifications (SOP 7-101-DS) and component identity testing and CoA review (SOP 7-102-DS).
Batch review and release: product hold and release, quality control unit responsibilities and material review, with the batch record review checklist.
Supplement Facts, label and claims review (SOP 7-106-DS) with a 21 CFR 101.36 and 101.93 checklist.
Serious adverse event reporting (SOP 8-101-DS) with intake form, log and FDA submission checklist for the 15-business-day deadline.
New dietary ingredient determination, food facility registration, complaints, returns, recall, CAPA, reserve samples, document control and records retention.
Part 111 Gap Assessment and Self-Inspection Checklist (FORM 0127-DS).
Who it is for
Own-label supplement brands, e-commerce sellers, practitioner brands and distributors who use a contract manufacturer.
What you receive
An instant download of one zip file with a READ ME, 4 lists, 17 procedures and 18 forms, all editable Microsoft Word files.
Need the full GMP system?
The Dietary Supplement cGMP Quality System ($1,195) includes this pack plus a complete 21 CFR Part 111 quality system of 112 documents.
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