U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Pressure Safe, LLC - 520442 - 06/07/2017
  1. Warning Letters

WARNING LETTER

Pressure Safe, LLC MARCS-CMS 520442 —


Recipient:
Pressure Safe, LLC


United States

Issuing Office:
Seattle District Office

United States


  

Department of Health and Human Services logo

 
 
U.S. Food and Drug Administration
Seattle District Office
22215 26th Avenue SE, Suite 210
Bothell, Washington 98021

 

June 7, 2017 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 17-17

Michael N. Morasch, President
Pressure Safe, LLC
P.O. Box 30028
Portland, Oregon 97294

WARNING LETTER

Dear Mr. Morasch:

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)].  Accordingly, the 100% juices processed by your firm are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.  You may find the Act, the juice HACCP regulation, and the juice HACCP Hazards and Controls Guidance through links on the FDA’s homepage at www.fda.gov
 
This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of our inspection on February 23, 2017.  We acknowledge receipt of your response letter dated March 10, 2017, which includes a description of corrective actions taken by your firm.  However, our review of the documentation revealed that your response was not adequate, as further explained in this letter.

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/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Juice/ucm072481.htm.

Your March 10, 2017, response to the FDA-483 indicates that one of your customers, (b)(4), has revised their recipes to meet a pH of (b)(4) or less in all juices they send for HPP processing, and that this change has been added to their HACCP plan.  Your response is not adequate in that you have not identified any control measures to ensure all of the juices you process are acidic or acidified (i.e. pH of 4.6 or less) nor have you provided a copy of (b)(4) updated HACCP plan.  We note that the HACCP plan you provided from one of your other customers, (b)(4), lists “pH ≤ (b)(4)” as a critical limit for juice before HPP processing, which is not adequate to control Clostridium botulinum.

In addition, for some of your refrigerated high acid juices, your firm has not validated that your HPP critical control point (CCP) consistently achieves a 5-log reduction of the pertinent pathogens.  Specifically, you process (b)(4) different juices with pH values less than 4.6 from (b)(4).  However, your firm relies on a validation study for a “(b)(4)” with a pH of (b)(4).  The study provides limited information regarding product characteristics other than the ingredient list and the pH.  There is no scientific support to indicate that this validation study applies to all of the actual products you process for (b)(4).  FDA is not aware of any broad HPP validation study that covers juice products with varying compositions, characteristics, pertinent microorganisms, etc.  FDA recommends validating your HPP processes for each type of juice products you process; working with a process authority; and providing data to demonstrate that a single HPP validation study can be applied to several juice products grouped together.  FDA would need to evaluate the validity of the data on a case-by-case basis.

2. You did not take corrective action that ensured affected product was not entered into commerce and the cause of the deviation was corrected, as required by 21 CFR 120.10(a).  Specifically, review of documentation obtained during our inspection revealed that on 01/21/17, 01/27/17, and 02/10/17 you deviated from your critical limit of (b)(4) psi for (b)(4) seconds listed in your HACCP plan at the HPP critical control point for the (b)(4) products.  HPP processing records demonstrated that none of the (b)(4) batches processed for (b)(4) on those dates maintained the minimum pressure of (b)(4) psi throughout the (b)(4) second process time.  In addition, the corresponding CCP monitoring records (b)(4) production report”) were not reviewed to verify that the documented values are within critical limits, as required by 21 CFR 120.11(a)(1)(iv)(A).

Your response states that you are unsure why the failure to achieve (b)(4) psi consistently is an issue.  However, during an HPP cycle the minimum pressure must be maintained for the entire duration of the minimum hold time; otherwise, a deviation has occurred and a corrective action must be taken.

Your response further states it is not part of your policy to review CCP monitoring records that are maintained electronically, and that you review your written records.  However, the actual pressures achieved are not recorded on your hand written “HPP MONITORING HACCP LOG.”  During our inspection, we observed that actual values for pressure at the High Pressure Processing critical control point are recorded electronically in the “(b)(4) production report.”  As noted in 21 CFR 120.12(g), the maintenance of computerized records is acceptable, in accordance with 21 CFR 11.  However, these CCP monitoring records are still subject to the records review requirements.

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.

In addition to the significant deviations above, FDA has the following comment with respect to the three validation studies provided by your customers.  The studies all conclude that the HPP processing conditions from the study result in at least a 5-log reduction and can be applied to juice with a pH equal to or less than the juice(s) studied. However, no scientific support was provided to substantiate such conclusion.  As stated above, FDA is not aware of any broad HPP validation study that covers juice products with varying compositions, characteristics, pertinent microorganisms, etc.  In addition, details of many potentially important product and processing conditions during validation are unknown, such as product water activity, percent solids, Brix, product temperature, and pressurization fluid temperature.  For each validation study, it appears that only one HPP process run with multiple samples was evaluated and there was no true replication of the HPP process to understand process variability. 

Lastly, your 483 response indicates you have revised your HACCP plan to include high pressure processing critical limits for all of your clients, in particular (b)(4).  However, you did not include a copy of your revised HACCP plan in your response.  We will verify your HACCP plan lists your current clients and the associated critical limits for their products during our next inspection at your facility.

Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs.  A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved.  Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)].  FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Please respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should outline the specific things that you are doing to correct these deviations.  You may wish to include in your response documentation such as your HACCP plan or other useful information that would assist us in evaluating your corrections.  If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

Your written response should be sent to the following address: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the

attention of Katherine L. Arnold, Compliance Officer.  Should you have any questions concerning this letter, you can contact Ms. Arnold at 425-302-0437.
       
Sincerely,
/s/
Miriam R. Burbach
District Director

cc: Oregon Department of Agriculture
     Food Safety Division
     635 Capitol Street NE
     Salem, Oregon 97310-0110