Food Safety and Foreign Material. (a) All corrective actions performed on product due to foreign material and/or processed/ unprocessed container mix-ups must be approved by FTR. NOTE: In addition to FTR approval, approval by the cognizant regulatory agency, FDA, USDA-FSIS, or USDC, is required. CONTINUED ON NEXT PAGE
Food Safety and Foreign Material. (a) All corrective actions performed on product due to foreign material and/or processed/ unprocessed container mix- ups must be approved by FTRC. FTRC approval may be accomplished by means of one the two following methods, the methods being subject to change as determined by the Contracting Officer to be necessary for determining FTRC approval:CONTINUED ON NEXT PAGE CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED: SPE3S1-23-R-0005 PAGE 22 OF 71 PAGES
Food Safety and Foreign Material. (a) All corrective actions performed on product due to foreign material and/or processed/ unprocessed container mix-ups must be approved by FTRC. NOTE: In addition to FTRC approval, approval by the cognizant regulatory agency, FDA, USDA-FSIS, or USDC, is required. (b) Any product that is offered to the Government that has been produced using a bulk product or an ingredient product lot(s) that has, at any time, been identified as containing or having contained foreign material must be approved by FTRC. The Contracting Officer must be informed and provided documentation identifying the foreign material and all corrective action taken to render the bulk/ingredient product serviceable. (c) Retesting/reinspection/rework of product that tested positive for food borne pathogens is not authorized. (d) These requirements are in addition to applicable Code of Federal Regulations or other regulatory requirements (USDA-FSIS, FDA). CONTINUED ON NEXT PAGE CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED: SPE3S1-16-R-0012 PAGE 18 OF 112 PAGES
Food Safety and Foreign Material. (a) All corrective actions performed on product due to foreign material and/or processed/ unprocessed container mix-ups must be approved by FTR. NOTE: In addition to FTR approval, approval by the cognizant regulatory agency, FDA, USDA-FSIS, or USDC, is required. (b) Any product that is offered to the Government that has been produced using a bulk product or an ingredient product lot(s) that has, at any time, been identified as containing or having contained foreign material must be approved by FTR. When product is presented for Government verification, the Government QAR must be informed and provided documentation identifying the foreign material and all corrective action taken to render the bulk/ingredient product serviceable. (c) Thermal process deviations or deviations from the preparation, formulation or critical factors cited in the approved process schedule must be accompanied bya detailed letter from the plant's Processing Authority. The involved sub-code(s), the deviation, and the disposition of the product shall be clearly identified when the complete lot is presented for Government end item verification inspection. If the producer fails to provide enough information/data in the case of a deviation, the GQAR shall contact FTR for approval to proceed with the Government end item verification inspection. (d) Retesting/re-inspection/rework of product that tested positive for food borne pathogens is not authorized. (e) These requirements are in addition to applicable Code of Federal Regulations or other regulatory requirements (USDA-FSIS, FDA). Note: Deviations (that occur during or prior to the production of a product) from specific preparation/ formulation/ingredient requirements cited in the specifications shall be submitted as a request for product deviation and must be approved and coordinated with the Specification Preparing Activity (Natick) through the applicable contracting officer. 3.