FDA

The FDA (U.S. Food and Drug Administration) sets rigorous standards for safety, efficacy, and quality of products sold in the U.S., covering food, drugs, medical devices, cosmetics, and dietary supplements. Mandatory for foreign businesses entering the world’s largest consumer market, FDA compliance is a global benchmark for product safety and regulatory excellence.​

1. Food Safety: Requires facility registration and adherence to FSMA (Food Safety Modernization Act), focusing on hazard analysis, preventive controls, and supply chain transparency. Prohibits adulteration and misbranding (e.g., unlabeled allergens).​

2. Drugs & Biologics: Demands extensive premarket approval (NDA/ANDA), including clinical trials and cGMP (current Good Manufacturing Practices) compliance for manufacturing quality.​

3. Medical Devices: Classifies devices into risk tiers (I–III), with high-risk devices needing premarket approval (PMA) and ISO 13485 conformity.​

4. Cosmetics & Supplements: Bans unsafe ingredients; requires accurate labeling for supplements (no unsubstantiated health claims) and safety documentation for cosmetics.​

U.S. Market Access: Essential for selling regulated products in the $15.5T U.S. market.​

Global Trust: FDA approval signals adherence to strict safety standards, boosting credibility worldwide.​

Risk Reduction: Minimizes liability from unsafe products and reputational damage in litigious markets.​

Regulatory Alignment: Aligns with global norms, easing multi-market compliance.​

Cost & Complexity: Drug/device approvals can cost millions, with extensive documentation.

Time Investment: Lengthy review processes require patience and resource planning.​

Ongoing Compliance: Continuous updates to regulations demand adaptive strategies.​

FDA certification is a strategic imperative for businesses targeting the U.S. and seeking global trust. While compliance requires effort, it unlocks access to a massive market and demonstrates a commitment to safety—critical in industries where regulatory excellence is non-negotiable.

Zhongye Foods (Dalian) Co., Ltd. has demonstrated remarkable compliance advantages and technical capabilities during its FDA certification process. The core competencies, corporate strengths, and value provided to industry clients through meeting and exceeding standards are as follows:

Implementing a three-tier supplier audit mechanism, the company requires all raw materials to provide FDA-approved safety certifications and conducts origin qualification reviews for imported materials. For example, raw materials for its sake, sauces, and other products have all passed FDA component safety assessments, avoiding the use of unapproved additives.

Utilizing internationally advanced automatic filling production lines, the company monitors critical parameters such as temperature, humidity, and microbial indicators throughout the process to ensure compliance with FDA's GMP requirements. The workshop is divided into independent clean zones, and equipment cleaning cycles and record accuracy exceed basic FDA requirements (e.g., ATP fluorescence testing after each production batch).

Establishing an HACCP system covering raw material inspection, sterilization processes, and finished product testing, the number of critical control points (CCPs) set is 20% more than FDA requirements.

Labels strictly adhere to the FDA's 2025 updated allergen labeling requirements, clearly indicating newly added allergens such as sesame and using bilingual Chinese-English warning statements (e.g., "Contains Sesame"). Meanwhile, labels are synchronized to comply with regulations in the EU, Japan, and other regions to meet different market demands.

FDA certification serves as the core pillar of Zhongye Food's global strategy. Its advantages in raw material control, production compliance, and technological innovation provide industry clients with comprehensive support from market access to brand value enhancement. With dual certification endorsement and technology-driven capabilities, Zhongye not only meets certification standards but also exceeds customer expectations through efficient traceability, customized solutions, and other measures, becoming a benchmark enterprise in the high-end food processing sector.