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FORM FDA 3511f (1/11)PAGE 1 of 7 INSTRUCTIONS Complete the question blocks below. Narrative responses to each item can be ent

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Content	FORM FDA 3511f (1/11)PAGE 1 of 7 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. Attach the diagram to the EIR as an exhibit. Measure and verify retort plumbing – record on this form. Report all pipe sizes as inside diameter (ID). Refer to FDA Guide to “Inspections of LACF Manufacturers,” Part 2, pp. 34-36, and 21 CFR Part 113.40(f). Before entering the interior of the retort, you must confirm with the firm that you are following the firm’s Standard Operating Procedures designed to meet OSHA confined space requirements. If the firm insists that only plant personnel enter the retort, witness the measurement procedure and data collection. To obtain OSHA confined space information and safety procedures, see the confined space presentation on the FDA ORAU web site. If the firm is not aware of the OSHA confined space requirements or does not have a confined space program, DO NOT ENTER THE RETORT. If problems are found with the firm’s retort equipment or processing system, refer the reader to the Turbo EIR for a narrative description of specific problems with supporting evidence, under “Objectionable Conditions and Management’s Response.” Submit the completed form as an EIR attachment. NO. OF CARRIER CHAINS COMPUTER CONTROLS DOES A COMPUTER CONTROL ANY OF THE RETORT FUNCTIONS? DOES THE FIRM HAVE DOCUMENTATION ON HAND WHICH INDICATES THAT THE COMPUTER SYSTEM HAS BEEN VALIDATED? EXPLAIN: IS RECORD KEEPING PART OF THE COMPUTER FUNCTION? COMMENTS: IF YES, DOES THE RECORD KEEPING COMPLY WITH 21 CFR PART 11? COMMENTS: MERCURY-IN-GLASS THERMOMETERS (113.40(f)(1)) IS THE RETORT EQUIPPED WITH AT LEAST ONE MERCURY-IN-GLASS (MIG) THERMOMETER? COMMENTS: IS THE RETORT EQUIPPED WITH ANOTHER TYPE OF TEMPERATURE INDICATOR DEVICE? IF YES, DESCRIBE THE INDICATOR. PSC Publishing Services (301) 443-6740 EF NO. OF CARRIERS IN STEAM DOME NO. OF CONTAINERS/CARRIERCONTAINER SIZE(S) PROCESSING IN STEAM IN HYDROSTATIC RETORTS (Retort Survey) DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION RETORT NO. RETORT DESCRIPTION Firm Name, City & State: Inspection Date(s): Investigators: FEI Number: FCE Number: .No Yes YesNo . .No Yes .No Yes .No Yes .No Yes
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Following Datasheets	UCM071653_1 (11 pages) UCM071661_1 (11 pages) UCM071670_1 (7 pages) UCM071977_1 (6 pages) UCM072017_1 (1 pages) UCM072080_1 (1 pages) UCM072759_1 (2 pages) UCM072770_1 (1 pages) UCM072772_1 (1 pages) UCM073395 (10 pages)
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