Product Specification Sheet – Your Product’s Technical Blueprint
A Product Specification Sheet is a required document under 21 CFR § 111.70 for dietary supplements. It defines the physical, chemical, and dosage characteristics of your finished product, helping ensure consistency, traceability, and FDA compliance from batch to batch.
Who Needs It?
- • Dietary Supplement Manufacturers formulating or producing finished goods
• Private Label Brands sourcing from contract manufacturers
• Importers who must verify product content for FDA and FSVP requirements
• Retailers & Brand Owners preparing for certification or eCommerce listing
Why It’s Required:
- • Required by FDA under cGMP guidelines (21 CFR § 111.70)
• Provides exact ingredient specs, dosage strength, color, odor, and more
• Needed for batch record matching and identity testing
• Requested during FDA inspections, FSVP verifications, and buyer audits
What’s Included:
- • Customized Product Specification Sheet Template
• Ingredient Identity, Strength, and Purity Definitions
• Dosage Form, Appearance, and Physical Properties
• Acceptance Criteria for Finished Product Release
• Integration with COA and Batch Record Documentation
• Regulatory Review & QA Oversight
What’s Included:
- • FDA Facility Registration (New or Renewal)
• U.S. Agent Appointment (for foreign facilities)
• Registration Confirmation and Number
• Biennial Renewal Reminders & Monitoring
• FDA Compliance Guidance & Support
Pricing:
| Service | Standard Price | Support360 Member Price (50% Off) |
|---|---|---|
| Product Specification Sheet Setup | $1,500 | $750 |
- Support360 Members receive 50% OFF product documentation services, including spec sheets, COAs, and batch record tools.
Risks of Operating Without a Spec Sheet:
- Without recognized certification, your brand may be:
- • Non-compliance with 21 CFR Part 111
• Inaccurate or unverified COAs
• FDA 483s or Warning Letters during inspections
• Rejection from buyers, platforms, and regulatory partners
