A gloved production worker assists with canning now that the FDA FCE SID is registered and verified.
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Registrar Corp

World's Leading FDA Compliance Experts

Discover What FDA Changes Have Affected FCE SID Filing

Aug 1, 2023

It’s common knowledge in the canning industry that the U.S. Food and Drug Administration (FDA) requires companies that produce certain Acidified and Low-Acid Canned Food (LACF) packaged in hermetically sealed containers to obtain a Food Canning Establishment (FCE) registration.  

It should also come as no surprise that FDA requires LACF and acidified food facilities to register unique process filings for each scheduled process used for the manufacturing of these categories of foods. The principal change we’ll talk about revolves around how each of these Process Filings boast a unique Submission Identifier (SID) number status.  

FCE and SID data is generally submitted to FDA for FDA review over their electronic filing system as a SID must be on file with FDA before the product is allowed entry to the United States. 

However, the system just received a change in how it handles SIDs. 

The Noteworthy FCE SID Electronic Filing Changes 

Recently, FDA implemented changes to their LACF electronic filing system. Of particular importance is the addition of a Not Filed-Incomplete status for SIDs, for which the manufacturer will receive an Electronic Incomplete Notification Event.  

What does this mean? If the SID submission is considered Incomplete, the Manufacturer cannot use the SID for shipments to the United States until the issue is resolved.  

It also bars the Manufacturer from packing the product using the Incomplete scheduled process. However, the Manufacturer will be given 30 days to reply to the “Incomplete” status before the filing is deleted. 

What You Can Do About the FCE SID Changes 

FDA will continue to update and change its regulations across industries — not just for food canning establishments. FCE SIDs are just the most recent example in the evolution of FDA regulations. But, there are a couple steps you can take to ensure your AF/LACF facility stays compliant amidst changes: 

Assure Proper Filing of Your FCE SID 

Incomplete SID submissions are not unusual as the FDA FCE SID submission process is complicated and time-consuming — especially for non-U.S. manufacturers.  

Verifying your FCE products’ SID numbers before shipping helps avoid time-consuming detentions, entry errors, and low filer evaluations. FCE Compliance tools like SID Verifiers make it easy to confirm whether your SIDs are on file in the FDA database. 

Assure Your Team’s Regulatory Compliance 

Selecting FDA-Approved Online FDA Better Process Control School Courses required for operators of LACF and acidified facilities goes a long way in keeping operations in compliance. 

Online training, especially those that cover BPCS, is an invaluable tool in keeping up with changes in FDA regulation. 

Avoid An “Incomplete” Status & Keep Product Moving With Registrar Corp 

With Registrar Corp, our team of food science specialists will determine which regulations you must comply with, help you register, and provide expert guidance along the way. We expedite the FCE compliance process for you leaving you free to focus on building a better product. 

Discover our full suite of FCE solutions available and keep your product out of detention by safeguarding against the FCE SID Incomplete Status.

Author


Registrar Corp

World's Leading FDA Compliance Experts

Registrar Corp thrives on the collective expertise of over 200 professionals, including former FDA officials and experienced industry specialists. Our team of regulatory specialists is our greatest asset, offering deep insights into the latest and longstanding FDA regulations. With our simple, straightforward, and actionable articles, you can navigate the complex regulatory landscape with ease.

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