FDA-3511c.p65 wwragg

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Specifications	FDA-3511c.p65 wwragg
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FORM FDA 3511c (3/07)PAGE 1 RETORT NO.*CAN SIZECOOKER CAPACITY COMPUTER CONTROLS DOES A COMPUTER CONTROL ANY OF THE RETORT FU

Specifications	FDA-3511c.p65 wwragg
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Content	FORM FDA 3511c (3/07)PAGE 1 RETORT NO.CAN SIZECOOKER CAPACITY COMPUTER CONTROLS DOES A COMPUTER CONTROL ANY OF THE RETORT FUNCTIONS?.Yes No EXPLAIN: DOES THE FIRM HAVE DOCUMENTATION ON HAND THAT INDICATES THAT THE COMPUTER SYSTEM HAS BEEN VALIDATED? Yes No EXPLAIN: IS RECORD KEEPING PART OF THE COMPUTER FUNCTION?.Yes No IF YES, DOES THE RECORD KEEPING COMPLY WITH 21 CFR PART 11?.Yes No COMMENTS: INDICATING MERCURY IN-GLASS THERMOMETERS (113.40(c)(1)) IS THE RETORT EQUIPPED WITH AT LEAST ONE MERCURY IN-GLASS (MIG) THERMOMETER?.Yes No COMMENTS: IS THE RETORT EQUIPPED WITH ANOTHER TYPE OF TEMPERATURE INDICATING DEVICE?.Yes No IF YES, DESCRIBE THE INDICATOR: ARE SCALE DIVISIONS EASILY READABLE TO 1°F (.5°C)?.Yes No PSC Graphics (301) 443-1090EF STEPS/REEL ○○○○○○○ ○○○○○○○ NO. OF PRECOOKERSNO. OF PRESS COOLERSNO. OF AMOS. COOLERS List the Can Size covered during the inspection. PROCESSING IN STEAM IN CONTINUOUS AGITATING RETORTS (Retort Survey) DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION INSTRUCTIONS Complete the question blocks below. Narrative responses to each item can be entered in the item’s “comments” area or where otherwise prompted. Draw a diagram of the retort or obtain one from the firm and attach it to the EIR as an exhibit. Report all pipe sizes as inside diameter (ID). Refer to 21 CFR Part 113.40(c) and pp 28-30 of LACF Guide Part 2. If problems are found with the firm’s retort equipment or processing system, refer the reader to the narrative Turbo EIR under “Objectionable Conditions and Management’s Response,” and include a narrative explanation of specific problems and evidence under the subheading “Supporting Evidence and Relevance.” Submit the completed form as an EIR attachment. RETORT DESCRIPTION Save As.Print Next Page Previous Page Reset Form
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