Many LACF and acidified food manufacturers believe they are in the clear once they have registered their facility and submitted a process filing for an SID number. However, we are seeing more clients have process filings rejected by the FDA because of significant gaps in supporting documentation—gaps that often lead to returned filings, follow-up questions, or citations. Plus, the FDA has increasingly emphasized the need for a formal Process Validation Report from a Recognized Process Authority.
Why this Matters
For companies registering a food canning facility—or those already registered but needing a SID number—these issues can stop the process cold, delaying you from getting your product into market.
In this webinar, we’ll break down the most common FDA deficiencies related to LACF and acidified food process filings and explain why many companies are surprised by FDA’s response. We’ll clarify what FDA expects to see—and where submissions most often fall short.
You’ll learn:
- Why a SID number does not confirm FDA acceptance
- The documentation issues FDA is actively citing
- What must be validated—and by whom
- What FDA considers a “recognized” Process Authority
- How to reduce the risk of returns, delays, and compliance setbacks
If you manufacture LACF or acidified foods, this session will help you uncover potential compliance risks before they result in costly FDA action.
About the Speaker:
Scott Cabes is Senior Director of Low Acid & Acidified Foods at TechniCAL, a Registrar Corp company and the world’s leading independent Process Authority. With over 30 years of experience, he is a recognized expert in FDA and USDA compliance for thermally processed foods and a sought after speaker on thermal processing and regulatory compliance.
For Medical Device Establishments, who must register?
Owners or operators of establishments involved in producing and distributing medical devices intended for the U.S. market must register annually with FDA and pay an annual registration fee.
What information is submitted for medical device establishment registration?
In addition to registering with FDA, most owners or operators of medical device establishments must also submit a list of all devices during their annual registration renewal.
- U.S. Facilities
- Initial importers must identify the manufacturers of the devices they are importing.
- A device must be listed if they fall under the any of the following:
- Contract Manufacturer
- Contract Sterilizer
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U. S. manufacturer of export only devices
- Non-U.S. Facilities
- Must list devices, provide a U.S. Agent, and identify importers.
Who must provide medical device listings?
In most cases, all medical device establishments required to register with FDA must also submit a complete list of medical devices manufactured for commercial distribution in the U.S. market.
All facilities that fall under any of the following functions:
- Contract Manufacturer
- Contract Sterilizer
- Foreign Exporter
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U.S. manufacturer of export only devices
What information is submitted for a medical device listing?
Medical device establishments must list any medical device made in the establishment and the activities the device is meant for.
- Company function (activity)
- Device product code
- Proprietary names
- Importer information
What is a master file?
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or the National Medical Products Association (NMPA) in China.
