Inspections, Compliance, Enforcement, and Criminal Investigations
Simmons Pet Food, Inc. 23-Jul-08
Department of Health and Human Services
Public Health Service
July 23, 2008
RETURN RECEIPT REQUESTED
Todd Simmons, President and CEO
Simmons Pet Food, Inc.
316 North Hico Street
P.O. Box 430
Siloam Springs, AR 72761
Dear Mr. Simmons:
On February 14-15, 2008, the U.S. Food and Drug Administration (FDA) conducted an inspection of your low-acid canned pet food manufacturing facility located at 316 North Hico Street, Siloam Springs, Arkansas.
We found that you have serious deviations from the Low-acid Canned Food regulations described in Title 21, Code of Federal Regulations (CFR), Part 108, Emergency Permit Control (21 CFR Part 108), and Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (21 CFR Part 113). As a manufacturer of low-acid canned pet 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. The Emergency Permit Control regulation was issued, in part, pursuant to section 404 of the Act (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 Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 113. In addition, failure to comply with 21 CFR 108.35 and the mandatory portions of Part 113, renders your low-acid canned pet food adulterated within the meaning of section 402(a)(4) of 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 may have been rendered injurious to health. You can find the Act and the Low-acid Canned Food regulations through links in FDA's home page at http://www.fda.gov.
Your significant violations were as follows:
1) Your firm has not established a product traffic control system to prevent unretorted product from bypassing the retort process [21 CFR 113.87(b)].
Specifically, both the top and bottom doors of each retort operate manually and can be opened at the same time. This system does not prevent cans falling directly through the retort into the cooling canal without being processed. We received your 483 response letter dated February 22, 2008, which states that retort banks [(b)(4)] have been or will be reprogrammed and rewired so that the upper and lower doors cannot be opened when the retort is in run mode. However, your response is incomplete because this correction does not address measures you have taken to prevent both doors from being opened simuitaneously when the retort is not in run mode.
2) Your firm's container cooling water was not chlorinated or otherwise sanitized as necessary for cooling canals and recirculated water supplies [21.CFR 113.60(b)]. Specifically, during the inspection, the cooling canal for retort bank [(b)(4)] was evaluated and found to contain no measurable amount of chlorine. The minimum standard range for chlorine in the cooling water, as set by your firm, is [(b)(4)]
Your February 22, 2008 response letter indicates your firm will create and implement a new standard operating procedure (SOP) requiring, when there is no evidence of detectable chlorine in a cooling canal, that a line be immediately stopped until chlorine can be manually added to the canal. Further, your response indicates that your firm moved the [(b)(4)] chlorine pump closer to the line for better functionality, However, your response is incomplete because it does not address either the outcome of the product that passed through the cooling canal when the chlorine level was outside of your minimum standard range or product processed since the last "in specification" result.
3) Your firm failed to record all process deviations involving a failure to satisfy the minimum requirements of the scheduled process, as well as the actions taken by your firm to either fully re-process or set aside and evaluate that portion of the production involved in the process deviations [21 CFR 113.89]. Specifically, a drop in process temperature below the scheduled process temperature was identified on the [(b)(4)] chart during record review for the processing day of February 12, 2008. The [(b)(4)] recording chart lacked proper identification of problems and corrective actions associated with the identified process deviation.
Your response letter dated February 22, 2008, indicated that retort operators will be retrained on [(b)(4)] Chart Recordings and that documentation will be kept. However, your response is incomplete because It does not address the actions taken by your firm to fully re-process or set aside and evaluate the portion of product affected by the process deviation that occurred on February 12.
4) Your firm's recording thermometer charts and container closure records were not adequately reviewed by representatives of plant management [21 CFR 113.100 [(b and c)]. Recording thermometer charts must be reviewed for completeness and to ensure that the product received the scheduled process, and they must be signed or initialed, and dated by a representative of plant management who is qualified by suitable training or experience. Container closure records must be signed or initialed by the container closure inspector and reviewed by management with sufficient frequency to ensure that the containers are hermetically sealed. Specifically, the following records were not reviewed:
• Thermometer Validation Log (# PFQSM-FORM-002) dated 1/12/08; 1/14/08 -- 1/17/08; 1/26/08 - 1/28/08; 1/31/08; 2/1/08 - 21 2/08; 2/4/08 -- 2/6/08.
• Production Report (container closure examinations) dated 3/30/07; 2/14/07; 5/30/07; 11/27/07; 12/26/07; 2/14/08.
Your February 22, 2008 response letter regarding the thermometer calibration log indicates that the log has been revised to remove the potential for ditto marks, that a member of the quality assurance management team will sign the log daily, that employees have been retrained on work instructions, and that responsible management personnel have been counseled. In addition, with regard to the analytical scales, your response letter indicates that employees have been retrained on work instructions and that management personnel responsible for signature sign-off have been counseled. Finally, with regard to the production report (container closure examination), your response indicates that employees have been retrained on work instructions, that your firm has addressed the corrective action that must be taken for out of specification events, and that management personnel responsible for signature sign-off have been counseled. However, your response is incomplete because it does not address with sufficient specificity actions taken by your firm to ensure that representatives of plant management who are qualified by suitable training or experience will review, sign, and date records as required by 21 CFR 113.100(b) and (c).
The above is not intended to be an all-inclusive list of deficiencies in your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct these deviations. Failure to do so may result in regulatory action without further notice. These actions include seizure or issuance of an order of need for a Temporary Emergency Permit.
Please notify this office in writing, within fifteen (15) working days from receipt of this letter as to the specific steps you. have taken to correct the stated deviations, including an explanation of each step taken to prevent their recurrence. Your response should also. indicate the person responsible for effecting corrective actions and include any supporting documentation indicating correction has been achieved. 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 deficiencies.
Your written response should be sent to Sherrie L. Krolczyk, Compliance Officer, at the address indicated on the letterhead. If you have any questions, please call Ms. Krolczyk at (214) 253-5312 or write to her at the address in the letterhead.
Reynaldo R. Rodriguez,
Dallas District Director