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Label Compliance Review

Complete FDA label review for dietary supplements, food products, or cosmetics. We check every element — Supplement Facts panel, ingredient lists, claims, allergen declarations, and required statements.

  • Full label markup with corrections
  • FDA regulation citations
  • Compliant label template
  • One round of revisions
$299 /SKU
2 business days
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🛒

Amazon / TikTok Listing Audit

Audit your product listing for FDA compliance issues that could trigger removal. We review titles, bullet points, images, and claims against FDA advertising regulations.

  • Listing compliance report
  • Flagged claims with alternatives
  • Compliant copy suggestions
  • Platform-specific guidance
$199 /listing
3 business days
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🇪🇸

FDA US Agent (Annual)

Registered US Agent service for foreign establishments. Required by FDA for all foreign food, drug, device, and cosmetic facilities exporting to the US.

  • FDA US Agent registration
  • Annual renewal management
  • FDA correspondence handling
  • Inspection coordination support
$499 /year
1 business day
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💄

MoCRA Cosmetics Package

Full MoCRA (Modernization of Cosmetics Regulation Act) compliance package. Facility registration, product listing, adverse event reporting setup, and label compliance.

  • FDA facility registration
  • Product listing submission
  • Label compliance review
  • Adverse event SOP template
  • MoCRA compliance certificate
$899
4 business days
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🔧

GMP Gap Analysis

Comprehensive review of your manufacturing processes against FDA cGMP requirements (21 CFR Part 111/117/211). Identify gaps before FDA does.

  • Facility documentation review
  • Gap analysis report
  • Corrective action plan
  • SOP templates (5 core SOPs)
  • Follow-up consultation call
$1,800
5-day delivery
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🩺

Medical Device Services

510(k) premarket notification support, FDA device registration, classification guidance, and ongoing compliance for Class I and Class II medical devices.

  • Device classification research
  • 510(k) submission support
  • FDA establishment registration
  • Device listing
  • Quality System (QSR) consulting
Custom Quote
Contact us for details
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FDA Regulatory Experts · Irvine, CA · keccfda.com
Advisor

Amy Chen

FDA Regulatory Advisor · KECC

Hi! I'm Amy, KECC's FDA compliance advisor. 👋

Ask me anything about FDA US Agent, MoCRA, label review, or 510(k).

你好!有任何 FDA 合规问题都可以问我 😊