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Low Acid Canned Foods (LACF) Compliance Services

Comprehensive FDA Compliance Solutions for Low Acid Canned Foods

Low Acid Canned Foods (LACF)—such as vegetables, soups, meats, and seafood—require strict regulatory compliance due to the risk of Clostridium botulinum contamination. The FDA enforces 21 CFR Part 113, which mandates:

  • Proper facility registration with the FDA.
  • Filing of scheduled thermal processing procedures (SID filings).
  • Accurate thermal process validation to ensure microbial safety.
  • Adherence to Good Manufacturing Practices (GMP) specific to LACF production.

Non-compliance can lead to import detentions, product recalls, and severe regulatory penalties. Our LACF Compliance Services provide tailored solutions that ensure safe, compliant, and efficient entry of your products into the U.S. market.

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Why LACF Compliance is Critical

Low Acid Canned Foods are highly regulated because improper processing can lead to the growth of Clostridium botulinum, which causes botulism, a potentially fatal illness. The FDA requires that all LACF manufacturers:

  • Register facilities with the Food Canning Establishment (FCE) database.
  • Submit scheduled process filings (SID) for each product variant.
  • Validate thermal processing methods to ensure product safety.
  • Follow GMP standards for consistent product quality.

Failure to comply with these requirements can result in shipment rejections, costly recalls, and damaged brand reputation.

Low Acid Canned Foods Services

Our Core LACF Compliance Services

FDA Facility Registration (FCE) for LACF Manufacturers

All facilities involved in producing LACF for U.S. distribution must register with the FDA. We handle the registration process, ensuring error-free submissions and timely renewals to maintain uninterrupted market access.

  • Submission of Food Canning Establishment (FCE) registration
  • Biennial renewal management for active compliance
  • U.S. Agent services for foreign manufacturers

Scheduled Process Filing (SID) Submission Support

Each LACF product requires an FDA-approved scheduled process to ensure safety during storage. We will assist you in preparing and submitting SID filings that meet FDA standards through our expert PCQIs.

  • 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 & Optimization

Proper thermal processing is critical for eliminating Clostridium botulinum spores. We ensure your thermal processing procedures meet FDA safety standards through comprehensive validation and optimization services.

  • 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

Manufacturers of LACF must comply with GMP under 21 CFR Part 113. Our GMP audits ensure that your facility follows industry best practices for consistent quality and regulatory compliance.

  • On-site GMP readiness audits for LACF operations
  • Development of Standard Operating Procedures (SOPs) tailored to LACF
  • Employee training programs focused on LACF safety protocols

Labeling Compliance for LACF Products

Accurate labeling is essential for meeting FDA requirements and ensuring product safety. We review your LACF product labels for compliance, reducing the risk of import detentions.

  • Ingredient list validation and allergen disclosure compliance
  • Country of origin labeling for imported LACF products
  • Safe handling instructions and storage condition guidance

FDA Inspection Preparation & Support

The FDA regularly inspects LACF manufacturing facilities on a random basis. We provide end-to-end inspection readiness services to help you pass with full compliance.

  • 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

Why Choose Our LACF Compliance Services?

Industry Expertise

Specialists in 21 CFR Part 113 LACF regulations and thermal processing standards.

Smart Solutions

All-in-one services, from FDA registration to process filing and inspection preparation

Risk Reduction

Proactive compliance strategies to prevent detentions, recalls, and supply chain disruptions

Efficient Market Access

Streamlined processes designed to accelerate FDA approval and reduce time-to-market.

Global Import Agent have successfully worked with me to land product in the U.S and remain compliant for FDA regulations. I'm really happy with their response times, and easy to use tech platform that facilitates the process.
Jane Mckay
Jane MckayAstute Beverages
I had hit a brick wall trying to get my FDA number for export of my rum to the USA. Ryan and James knew all the right contacts to sort this out for me. I could not have done it without Global Import Agent. They even sorted out my prior notification paperwork for me. I can highly recommend them.
James Singlehurst
James SinglehurstRevival Rum
Ryan, Chris and their team were exceptional in getting our food supplement product FSVP compliant. Pretty good experience with Global Import Agent overall.
Kelvin Yeo
Kelvin YeoAdvagen
Great level of service in the 3 months we have been working with Global Import Agent to date. From the first call with Fabrizzio to the comms with Ryan, James & Carlos, all has been good and the progress we are making is fantastic!
Jeff Webster
Jeff WebsterHunter & Gather
I recently had the pleasure of working with Ryan and his team for a label review of a dietary supplement, which was intended for commercialization in the United States. My experience was overwhelmingly positive, as they provided exceptional and professional support throughout the process.
Renato Di Lorenzi
Renato Di LorenziLoli Pharma
We use Global Import Agent as our FSVP agent for importing dietary supplements into the US from the EU. They've provided us with professional high-quality service thus far. Recommend!
Keiu Kadarik
Keiu KadarikEcosh Life
We were a start up working on our first import, and Global Import Agent was superb in taking care of our documentation and import process. Highly recommend.
Hee Joong Kim
Hee Joong KimMuom Life
Ryan is very helpful from the beginning to end. He responds super fast and he is on point to the issue / objectives.
Wonsik Woo
Wonsik WooLifeLab
James, Ryan and Carlos have been really helpful all along our FSVP. Great service.
Anahi Cabrera Herrera
Anahi Cabrera HerreraScience In Sport
Flexible and helpful FSVP agent. After comparing a couple of agents, this one is the one we picked. No regrets!
Andreas Edström
Andreas EdströmSwedish Signature AB
they are fast, efficient, and always open to help. They have been a great support for me and my company
Alba Rodríguez
Alba RodríguezGricha
Great to deal with, cost efficient and professional, highly recommended
Stephen Goument
Stephen GoumentGolden Turmeric
​What our clients say

Client Feedback

Read what our clients have to say about our services and how we have helped them export product.

Q. What is a LACF product?

LACF are foods that:

  • Have a pH greater than 4.6 and water activity greater than 0.85.
  • Are thermally processed and hermetically sealed.
  • Examples include canned vegetables, soups, meats, and seafood.

Q. What is the purpose of SID (Scheduled Process) filing?

SID filing provides the FDA with details about the thermal processing procedures used to ensure microbial safety in LACF. It includes:

  • Time, temperature, and pressure parameters for thermal processing.
  • Container closure systems to maintain product integrity.

Q. Why is thermal process validation critical?

  • Ensures the destruction of Clostridium botulinum spores.
  • Protects consumer health by preventing botulism.
  • Validations are conducted by certified Process Authorities to meet FDA standards.

Q. What are the consequences of non-compliance with LACF regulations?

  • FDA detentions and entry refusals at U.S. ports.
  • Product recalls, fines, and legal liabilities.
  • Potential brand damage and supply chain disruptions.

Q. Do foreign manufacturers of LACF products need a U.S. Agent?

  • Yes, foreign manufacturers must appoint a U.S.-based Agent for FDA communications.
  • We offer comprehensive U.S. Agent services to facilitate FDA interactions and ensure continuous compliance.

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Our tailored LACF Compliance Services provide end-to-end solutions, from facility registration and process filing to thermal processing validation and inspection readiness, ensuring your products meet FDA requirements for seamless market entry.

Our friendly team is always happy to help and will reach out as soon as possible.


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