Service overview
We register your canning establishment, prepare scheduled process (SID) filings and support thermal process validation and GMP, so your LACF products meet 21 CFR Part 113.
Why this service matters
- LACF products carry a risk of Clostridium botulinum, which causes botulism.
- The FDA requires FCE registration and a scheduled process filing for each product.
- Thermal processes must be validated and LACF-specific GMP followed.
- Non-compliance can lead to import detentions, recalls and regulatory penalties.
FDA Facility Registration (FCE) for LACF Manufacturers
All facilities producing LACF for US distribution must register with the FDA, and we handle the registration process.
- Submission of Food Canning Establishment (FCE) registration
- Biennial renewal management for active compliance
- US Agent services for foreign manufacturers
Low Acid Canned Food (LACF)
Scheduled Process Filing (SID) Submission Support
Each LACF product requires a scheduled process filed with the FDA, and our PCQIs help you prepare and submit SID filings.
- Preparation of SID documentation for all product variations
- Submission management via the FDA's FCE Online System
- Support for FDA feedback and resubmission processes
Thermal Process Validation & Optimisation
Proper thermal processing is critical for eliminating Clostridium botulinum spores, and we support validation of your thermal processes against FDA safety standards.
- Collaboration with certified Process Authorities for validation studies
- Analysis of retort parameters (time, temperature, pressure)
- Creation of process adequacy reports for FDA submission
LACF-Specific GMP Compliance Audits
LACF manufacturers must comply with GMP under 21 CFR Part 113, and our audits check your facility against these requirements.
- On-site GMP readiness audits for LACF operations
- Development of Standard Operating Procedures (SOPs) tailored to LACF
- Employee training programmes focused on LACF safety protocols
Labelling Compliance for LACF Products
We review your LACF product labels against FDA requirements to reduce the risk of import detentions.
- Ingredient list validation and allergen disclosure compliance
- Country of origin labelling for imported LACF products
- Safe handling instructions and storage condition guidance
FDA Inspection Preparation & Support
The FDA inspects LACF manufacturing facilities, and we help you prepare for inspections and respond to any findings.
- Pre-inspection audits to identify and resolve compliance risks
- Mock FDA inspections to prepare your staff and processes
- Assistance with FDA Form 483 responses and remediation planning
Ongoing compliance support
Time-Saving
We manage FCE registration and SID filings for each product, so submissions don't hold up production.
Regulatory Assurance
Filings and process documentation aligned with 21 CFR Part 113 requirements.
Peace of Mind
Reduce the risk of shipment rejections, recalls and damage to your brand.
What you'll need
LACF filings are technical, so prepare process data for each product.
- FCE registration detailsYour Food Canning Establishment information.
- Product variationsEach variation needs its own SID documentation.
- Retort parametersTime, temperature and pressure for your thermal process.
- A US AgentRequired for foreign LACF manufacturers.
Official sources
- 21 CFR Part 108: Emergency Permit Control (eCFR)
- 21 CFR Part 113: Thermally Processed Low-Acid Foods (eCFR)
- 21 CFR Part 1 Subpart H: Registration of Food Facilities (eCFR)
- Registration of Food Facilities and Other Submissions (FDA)
- 21 CFR Part 101: Food Labeling (eCFR)
- Nutrition, Food Labeling, and Critical Foods (FDA)