FDA Approved Storage Facilities: Requirements & Container Standards

Quick answer: There is no formal "FDA approved" status for storage facilities; instead, facilities that hold food must register with the FDA under the Bioterrorism Act, comply with cGMP under 21 CFR Part 117, and remain subject to FSMA inspection. Containers used in these facilities must meet 21 CFR 177.1520 material standards.

Part of our FDA & Food Safety Guide for Industrial Containers • See also: FDA Food Grade Warehouse Requirements

What Makes a Storage Facility "FDA Approved"?

Strictly speaking, the FDA does not "approve" storage facilities — it registers and inspects them. A facility that stores, distributes, or holds food products intended for human or animal consumption must be:

When people search for "FDA approved storage facilities," they typically mean facilities that meet all registration, compliance, and inspection requirements to legally store food, pharmaceutical, or dietary supplement products.

FDA Facility Registration Requirements

Who Must Register?

Any facility that manufactures, processes, packs, or holds food for consumption in the United States must register with the FDA, including:

Registration Process

Important: Registration does NOT mean FDA approval. It means the FDA knows your facility exists and can inspect it at any time.

Container Standards for FDA-Compliant Storage

Material Requirements

All containers used in FDA-registered storage facilities must meet specific material standards:

Container Compliance Checklist

Why HDPE Containers Are the Standard

HDPE (High-Density Polyethylene) has become the de facto standard for FDA-compliant storage facilities because:

Cold Storage Facility Requirements

USDA & FDA Cross-Requirements

Facilities that store temperature-sensitive products must comply with both FDA and USDA requirements:

Cold Storage Container Solutions

For facilities requiring cold chain compliance:

FSMA Compliance for Storage Facilities

Preventive Controls Rule (21 CFR Part 117)

The most impactful FSMA regulation for storage facilities requires:

Sanitary Transportation Rule (21 CFR Part 1, Subpart O)

Facilities involved in food transport must also comply with FSMA sanitary transportation requirements:

FDA Inspection Preparation Checklist

Before the Inspector Arrives

During the Inspection

SQF Certification for Enhanced Compliance

Many FDA-registered storage facilities pursue SQF (Safe Quality Food) certification as an additional quality standard:

SQF certification demonstrates to customers and auditors that your facility exceeds minimum FDA requirements, which is increasingly demanded by major retailers and food manufacturers.

Container Solutions for FDA-Compliant Facilities

LT Plastics provides the complete range of FDA-compliant containers for registered storage facilities:

FAQ

Does FDA registration mean a facility is FDA approved?

No. Registration only means the FDA is aware the facility exists and can inspect it; it does not constitute approval or certification of the facility's practices.

Who must register a food storage facility with the FDA?

Any facility that manufactures, processes, packs, or holds food for US consumption must register, including warehouses, cold storage facilities, fulfillment centers, and 3PL providers handling food.

What container standards apply inside FDA-registered storage facilities?

Containers must be made of FDA-compliant materials like HDPE under 21 CFR 177.1520, have smooth non-porous surfaces free of cracks or crevices, be cleanable, and be labeled for traceability.

How often must a food facility renew its FDA registration?

Registration must be renewed biennially, during the period of October 1 through December 31 of even-numbered years, through the FDA's FURLS system.

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