A Warning Letter was issued by FDA to a acidified food processor for not verifying equilibrium pH. (Equilibrium pH is measuring the pH after 24 hours to ensure that low acid components within the finished product are below 4.6 in order to prevent Clostridium botulinum growth).
Along with this, there was the lack of production and processing records showing adherence to scheduled processes, lack of a recall procedure, and they were not documenting the calibration of pH meter or the accuracy checks of thermometers and were using expired buffer solutions for pH meter calibration.
There are many small processors who focus on acidified foods. With FSMA, more of these processors will fall under FDA jurisdiction / regulations.
For someone looking for co-packing, it is critical to review a companies capabilities beyond what is on the website. Looking at this
company's website, you would think that these folks were operating correctly. This includes looking at audit reports, and of course, any FDA warning notices.
FDA Warning Lettershttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm465325.htmBackwoods Food Mfg Co Inc 9/15/15September 15, 2015
2015-DAL-WL-30
Danielle (NMI) Coursey, President, Co-Owner Michael R. Coursey, Vice-President, Co-Owner
Backwoods Manufacturing, Inc
591 Main Parkway
Tahlequah, OK 74464
Dear. Ms. Coursey, On March 24-26, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 591 Main Parkway, Tahlequah, OK, where you manufacture a variety of acidified foods. The inspection revealed serious violations of the regulations for acidified foods (Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108) and Part 114, Acidified Foods (21 CFR Part 114)). Accordingly, we have determined that your acidified food products are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the Acidified Food regulations through link in FDA’s home page at
http://www.fda.gov.