Is Pressure Safe, LLC Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

This letter may not list all the violations at your facility.  You are responsible for ensuring that your firm operates in compliance with the Act, the juice HACCP regulation (21 CFR 120), and all other applicable regulations.  You also have a responsibility to use procedures to prevent future violations of the Act and all applicable regulations.  You should take prompt action to correct these violations cited in this letter.  Failure to do so may result in enforcement regulatory action being initiated by the FDA without further notice.  These actions include, but are not limited to, seizure and/or injunction.

Potential Health Risks

The United States Food and Drug Administration (FDA) inspected your facility conducting high pressure processing of juice products, located at 23365 NE Halsey Street, Wood Village, Oregon, from February 13 - 15, 2017, and February 22 - 23, 2017.  The inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120).  In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 120, renders the juice products 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)]. 

Regulatory Context

The significant violations include, but are not limited to, the following:

1. You must include in your HACCP plan control measures that will consistently produce, at a minimum, a 5-log reduction of the pertinent microorganism, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR 120.24(a).  Specifically, your HACCP plan, titled “Juice, Beverage Product,” does not include control measures that achieve a minimum 5-log reduction of the pertinent microorganisms for all of the 100% juice products you process.  This is based on our finding that your firm has not adequately validated, as required by 21 CFR 120.11(b), that your high pressure process achieves a minimum 5-log reduction of the most pertinent organism for all of your 100% juice products.

For the refrigerated low acid 100% juice products you process, your firm must validate that the controls in your “Juice, Beverage Product” HACCP plan consistently achieve a minimum 5-log reduction of Clostridium botulinum, the pertinent microorganism for these products.  The only critical control point identified on your HACCP plan is the high pressure processing (HPP).  FDA does not consider HPP to be a validated process that can eliminate the spores of Clostridium botulinum in low acid juices.  In fact, non-proteolytic spores of Clostridium botulinum can grow and produce toxin in low acid juices even under refrigerated temperatures.  For further information related to microbiological concerns in low acid juice products, please reference this FDA guidance document:www.fda.gov/Food/Guidanc