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WARNING LETTER

Oregon Wild Berries, Inc. MARCS-CMS 528092 — 09/08/2017

Oregon Wild Berries, Inc. - 528092 - 08/09/2017


Recipient:
Oregon Wild Berries, Inc.


United States

Issuing Office:
Seattle District Office

United States


 

  

Black HHS-Blue FDA Logo

 

Seattle District Office
22215 26th Avenue SE, Suite 210
Bothell, Washington 98021 

 
 

 

August 9, 2017                                
 
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
In reply, refer to Warning Letter SEA 17-19
 
Stanley J. Egaas, President
Oregon Wild Berries, Inc.
dba Chef Edwin’s Soup
77129 Watach Drive
Clatskanie, Oregon 97016
 
WARNING LETTER
 
Dear Mr. Egaas:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your low-acid canned food processing facility located at 49279 Highway 30, Westport, Oregon, on May 9, 2017, through May 23, 2017. The inspection found that your firm manufactures low-acid canned food products including soup concentrate of clam chowder, oyster stew, smoked salmon chowder, mushroom soup, and roasted tomato soup. The inspection revealed serious violations of the low-acid canned food regulations (LACF), Title 21, Code of Federal Regulations, Part 113 (21 CFR 113). 
 
As a manufacturer of low-acid canned food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of low-acid canned food products. These regulations are described in 21 CFR 108, Emergency Permit Control, and 21 CFR 113, Thermally Processing Low-Acid Foods Packaged in Hermetically Sealed Containers. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for low-acid canned foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements of 21 CFR 113.
 
Based upon certain criteria in 21 CFR 113, low-acid canned foods may be adulterated within the meaning of section 402(a)(4), 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 low-acid canned food regulations through links on FDA’s home page at www.fda.gov.
 
We received your response on June 1, 2017, to the Form FDA 483, Inspectional Observations, issued to you at the close of the inspection. Your firm’s response included several attachments without a narrative description of the corrective actions taken by your firm. We address the attachments below, in relation to each of the noted violations.
 
1.    Your firm failed to provide evidence in the form of heat distribution data to demonstrate the adequate venting of air in your (b)(4) retort in which you use (b)(4), as required by 21 CFR 113.40(a)(12). Specifically, your firm is currently using a venting schedule of a minimum of (b)(4) minutes at (b)(4)ºF, which follows the established venting schedule in 21 CFR 113.40(a)(12)(ii)(B)(2) for (b)(4) vent. However, your firm was observed using (b)(4) in the (b)(4) retort and you have no data on file to demonstrate this venting schedule is appropriate with the use of (b)(4). Additionally, it was also noted that your process records for documenting the retort process do not consistently include the following required parameters regarding the vent schedule: time that (b)(4) is turned on and the temperature the vent was closed. 
 
We reviewed your response, received June 1, 2017, and find no responsive material to this observation. As such, your response is inadequate.
 
2.    Your firm failed to measure and record critical factors specified in the scheduled process at intervals of sufficient frequency to ensure that the factors were within the limits specified in the scheduled process, as required by 21 CFR 113.40(a)(13). Specifically,
 
a.  Review of the most recent (b)(4) production dates ranging from July 19, 2016, to May 16, 2017, found that your production records for clam chowder concentrate packed in pint glass jars do not include the critical factors of potato dimensions, cooling overpressure time and temperature, and headspace.
 
b.  Review of the most recent (b)(4) production dates on (b)(4), found that your production records for clam chowder concentrate packed in quart glass jars do not include the critical factors of potato dimensions, cooling overpressure time and temperature, and headspace.
 
c.  Review of the most recent (b)(4) production dates ranging from August 2, 2016, to May 25, 2017, found that your production records for smoked salmon chowder concentrate in pint glass jars do not include the critical factors of potato and salmon dimensions, cooling overpressure time and temperature, and headspace.
 
d.  Review of the most recent (b)(4) production dates ranging from May 17, 2016, to May 3, 2017, found that your production records for oyster stew soup concentrate in pint glass jars do not include the critical factors of cooling overpressure time and temperature, and headspace.
 
e.  Review of the most recent (b)(4) production dates ranging from July 7, 2015, to (b)(4), found that your production records for roasted tomato soup concentrate in pint glass jars do not include the critical factors of onion dimensions, cooling overpressure time and temperature, and headspace.
 
We reviewed your response, received June 1, 2017, which included blank, revised production records, and find it partially adequate. We acknowledge the revised production record includes a space for recording the overpressure time and temperature. However, the form also includes a single blank line for each of the following: particle size, head space, glass check, and sealed. The critical factors specified in the scheduled process need to be measured and recorded at intervals of sufficient frequency to ensure the factors are within the limits specified in the scheduled process. It is unclear from the provided record the frequency with which your firm will measure the particle size, head space, glass jars, and the seal on the jar and whether you will record actual measurements taken at each interval. Your response provides no narrative description of corrective actions your firm will take to ensure this violation does not recur. 
 
3.    Your firm failed to identify deviations from the filed scheduled process as required by 21 CFR 113.89. Specifically, your process authority states that your scheduled process for clam chowder concentrate are adequate for “self-venting glass jars that are processed with (b)(4) where the (b)(4) do not rest directly on the jars.” However, the following observations were noted during the inspection:
 
a.  On May 9, 2017, (b)(4) were observed in the (b)(4) retort resting directly on jars of clam chowder that had been processed on May 8, 2017, and assigned lot code 112817. 
 
b.  On May 16, 2017, (b)(4) were observed in the (b)(4) retort resting directly on jars of clam chowder prior to processing and assigned lot code 113617.
 
We reviewed your response, received June 1, 2017, and find no responsive material to the use of (b)(4) resting directly on the jars in deviation of your scheduled process. As such, your response is inadequate.
 
4.    Your firm failed to record the results of visual examination of the container closures at intervals of sufficient frequency to ensure proper closure, as required by 21 CFR 113.60(a). 
 
We reviewed your response, received June 1, 2017, which included blank, revised production records. The form includes a single blank line for “sealed”. As previously stated, it is unclear from the provided record whether actual observations will be recorded and that the observations for container closures will be made at intervals of sufficient frequency to ensure proper closure. Your response provides no indication of what your firm will be observing to ensure proper closure and what inspections and tests will be conducted to ensure consistent hermetic seal production. Your response provides no narrative description of corrective actions your firm will take to ensure this violation does not recur. As such, your response is inadequate.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure, injunction, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
 
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
 
Please notify this office in writing within fifteen (15) business days from the date you receive this letter describing the specific steps you have taken to correct the noted violations, and to prevent these violations from recurring or other similar violations from occurring. You should include documentation of corrective actions you have taken to date. If your firm will not be able to complete corrective actions before you respond, please state the reason for the delay and include a timetable for implementation of those corrections. Please include a narrative description of the corrective actions.
 
Your response should be sent to U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Compliance Officer Jessica L. Kocian. If you have any questions regarding this letter, please contact Compliance Officer Jessica Kocian by telephone at (425)-302-0444.
 
Sincerely,
/S/ 
Miriam R. Burbach
District Director
 
cc: 
Oregon Department of Agriculture
Food Safety Division
635 Capitol Street NE
Salem, Oregon 97301