| Specifications | Processing in Steam in Discontinuous Agitating Retorts Form FDA 3511d PSC Graphics |
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| Specifications | Processing in Steam in Discontinuous Agitating Retorts Form FDA 3511d PSC Graphics |
| Business section |
| Specifications | Processing in Steam in Discontinuous Agitating Retorts Form FDA 3511d PSC Graphics |
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| Content | Firm Name, City & State: Inspection Date(s): Investigators: FEI Number: FCE Number: 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 21 CFR Part 113.40(d) and p. 31 of LACF Guide, Part 2. 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. COMPUTER CONTROLS DOES A COMPUTER CONTROL ANY OF THE RETORT FUNCTIONS? EXPLAIN: DOES THE FIRM HAVE DOCUMENTATION ON HAND WHICH INDICATES THAT THE COMPUTER SYSTEM HAS BEEN VALIDATED? EXPLAIN: INDICATING MERCURY-IN-GLASS THERMOMETERS (113.40(d)(1)) PSC Publishing Services (301) 443-6740 EF PROCESSING MODE Axial End-over-End Rocking PROCESSING IN STEAM IN DISCONTINUOUS AGITATING RETORTS (Retort Survey) DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION RETORT NO. & DIMENSIONS*CAN SIZECOOKER CAPACITYSTEPS/REEL * List the can size covered during the inspection. RETORT DESCRIPTION YesNo . YesNo . IS RECORD KEEPING PART OF THE COMPUTER FUNCTION? IF YES, DOES THE RECORD KEEPING COMPLY WITH 21 CFR PART 11? COMMENTS: . YesNo . No Yes IS THE RETORT EQUIPPED WITH AT LEAST ONE MERCURY-IN-GLASS (MIG) THERMOMETER?.No Yes IS THE RETORT EQUIPPED WITH ANOTHER TYPE OF TEMPERATURE INDICATOR DEVICE? IF SO, DESCRIBE THE INDICATOR: .No Yes PAGE 1 of 8FORM FDA 3511d (1/11) |
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| Following Datasheets | UCM071615_1 (11 pages) UCM071640_1 (7 pages) 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) |
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