Aseptic Processing & Packaging Report FORM FDA-3511-3 PSC Graphics

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Specifications	Aseptic Processing & Packaging Report FORM FDA-3511-3 PSC Graphics
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FORM FDA 3511-3 (7/10)PAGE 1 of 18 Firm Name, City & State: Inspection Date(s): Investigators: FEI Number: FCE Number: DE

Specifications	Aseptic Processing & Packaging Report FORM FDA-3511-3 PSC Graphics
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Content	FORM FDA 3511-3 (7/10)PAGE 1 of 18 Firm Name, City & State: Inspection Date(s): Investigators: FEI Number: FCE Number: DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION ASEPTIC PROCESSING AND PACKAGING REPORT This inspection report is available in PDF on the forms site: http://www.fda.gov/opacom/morechoices/fdaforms/ora.html. Narrative responses to each item can be entered in the item’s “comments” area or where otherwise prompted. Complete documentation of deficiencies, including deviations from Part 113, should be narrated with reference to photos, exhibits, etc., in the EIR under “Objectionable Conditions and Management’s Response.” Under “Container Sterilizing, Filling AND Closing Operations” (pp. 11-16), answer only questions pertaining to operations observed during the inspection. When necessary, refer the reader to the appropriate section of the EIR for a full explanation of details. This form should be downloaded from the forms site prior to completion and copying. Submit the finished report as an attachment to the EIR. ESTABLISHMENT REGISTRATION – 108.35(c)(1) 1. HAS THE FIRM REGISTERED ITS PROCESSING ESTABLISHMENT WITH FDA? IF FIRM HAS REGISTERED, THE FCE NO. IS . COMMENTS: PROCESS ESTABLISHMENT AND FILING – 108.35(c)(2), 113.83 2. HAVE SCHEDULED PROCESSES BEEN FILED WITH FDA LISTING ALL CRITICAL FACTORS NECESSARY TO ACHIEVE COMMERCIAL STERILITY FOR THE PRODUCT, THE PRODUCT STERILIZATION SYSTEM, THE PACKAGING STERILIZATION SYSTEM AND THE PACKAGING MATERIAL? COMMENTS: 3. HAVE SCHEDULED PROCESSES USED BY THE FIRM BEEN RECOMMENDED BY A PROCESS AUTHORITY (LETTER, BULLETIN, SOP MANUAL, ETC.)? COMMENTS: 4. DOES THE FIRM HAVE A PROCESS LETTER OR OTHER DOCUMENTATION LISTING CRITICAL FACTORS NECESSARY TO CONTROL IN THE ATTAINMENT OF COMMERCIAL STERILITY? COMMENTS: 5. ARE FILED PROCESSES AT LEAST EQUAL TO RECOMMENDED PROCESSES PROVIDED BY THE PROCESS AUTHORITY? COMMENTS: 6. DOES THE FIRM HAVE ON FILE SUPPLEMENTAL INFORMATION LISTING PROCEDURES FOR PRE-STERILIZATION AND STERILITY MAINTENANCE OF PROCESSING AND PACKAGING EQUIPMENT AND STERILIZATION OF PACKAGING MATERIAL? COMMENTS: PSC Graphics (301) 443-1090 EF . . . YesNo . No Yes YesNo . No Yes YesNo . No Yes
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