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Address: 922 Country Rt 53, Brasher Falls, NY, 13613
Establishment No.: m4499
USDA Inspection Report: 2 Jun 2011
Violation: 417.2(a)(1), 417.2(c)(7), 417.4(a)(2)(ii), 417.4(a)(2)(iii), 417.4(a)(3), 417.5(a)(2), 417.5(a)(3), 417.5(b)
Citation: During a Food Safety Assessment (FSA) the following noncompliances were noted by EIAO [redacted] 1) The establishment did not reassess this HACCP plan for the 2010 calendar year. This is a noncompliance with 9 CFR 417.4 (a) 3, which requires that "every establishment shall reassess annually and whenever any changes occur that could affect the hazard analysis or alter the HACCP plan." 2) For CCPB1 cold storage: The establishment does not list the thermometer calibration procedure in the HACCP plan. This is a noncompliance with 9 CFR 417.2 (c) (7). 3) The stem thermometer calibration procedure on file does not support the frequency of "[redacted] in the HACCP plan for process-monitoring calibration activities, as it does not specify a frequency of calibration. This is a noncompliance with 9 CFR 417.5 (a) 2. 4) The establishment is not [redacted] as described in the HACCP plan for CCP B-1. This is a noncompliance with 9 CFR 417.4 (a) 2( iii ). 5) The establishment has not recorded the results of the verification activities for CCP-B1; this is a noncompliance with 9 CFR 417.5 (a) 3. 6) The establishment is not conducting or recording direct observation at the time the event occurs as the times recorded are after the official inspection hours. This is a noncompliance with 9 CFR 417.5 (b). 7) For CCP-B6 the HACCP plant lists "[redacted]." The frequency of direct observation activities is not listed in the HACCP plan for CCP-B6. This is a noncompliance with 9 CFR 417.2 (c) 7. 8) The establishment has not listed specific procedures in the HACCP plan that outlines the steps of verification or how the establishment is performing direct observation and record review. This is a noncompliance with 9 CFR 417.2 (c) (7). 9) For the cooking, cooling, fermentation and mixing CCPs, the establishment has not maintained a record keeping system that demonstrates they have met the requirements of the direct observation and record review verification activities required by the HACCP regulations. The establishment has not met 9 CFR 417.5 (a)3 and 9 CFR 417.4 (a) 2 (ii). 10) The establishment has not identified the scales used to [redacted] as process monitoring instruments and has not addressed scale calibration or accuracy in the hazard analysis or HACCP plan. The establishment did not identify preventive measures for the scales or identify the risk of adding too much or too little of the antimicrobial due to accuracy of the scales. This is a noncompliance with 9 CFR 417.2 (a).
417.2(a)(1) Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls. (2) A flow chart describing the steps
417.2(c)(7) List the verification procedures, and the frequency with which those procedures will be performed, that the establishment will use in accordance with §417.4 of this part.
417.4(a)(2)(ii) Direct observations of monitoring activities and corrective actions; and
417.4(a)(2)(iii) The review of records generated and maintained in accordance with §417.5(a)(3) of this part.
417.4(a)(3) Reassessment of the HACCP plan. Every establishment shall reassess the adequacy of the HACCP plan at least annually and whenever any changes occur that could affect the hazard analysis or alter the HACCP plan. Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product formulation; slaughter or processing methods or systems; production volume; personnel; packaging; finished product distribution systems; or, the intended use or consumers of the finished product. The reassessment shall be performed by an individual trained in accordance with §417.7 of this part. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan no longer meets the requirements of §417.2(c) of this part.
417.5(a)(2) The written HACCP plan, including decisionmaking documents associated with the selection and development of CCP’s and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures.
417.5(a)(3) Records documenting the monitoring of CCP’s and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment’s HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.
417.5(b) Each entry on a record maintained under the HACCP plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee making the entry.