FDA LACF Inspection Report FORM FDA-3511 PSC Graphics

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Specifications	FDA LACF Inspection Report FORM FDA-3511 PSC Graphics
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FORM FDA 3511 (7/10)PAGE 1 of 15 Firm Name, City & State: Inspection Date(s): Investigators: FEI Number: FCE Number: FDA

Specifications	FDA LACF Inspection Report FORM FDA-3511 PSC Graphics
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Content	FORM FDA 3511 (7/10)PAGE 1 of 15 Firm Name, City & State: Inspection Date(s): Investigators: FEI Number: FCE Number: FDA LACF INSPECTION REPORT DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION PSC Graphics (301) 443-1090 EF 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 Turbo EIR under “Objectionable Conditions and Management’s Response.” When necessary, refer the reader to the appropriate section of the Turbo EIR for a full explanation of details. This form should be downloaded from the forms site prior to completion and copying. The finished report should be submitted as an attachment to the Turbo EIR. PROCESS ESTABLISHMENT, FILING AND SCHEDULES 1. HAS THE FIRM REGISTERED WITH FDA AND FILED A PROCESS FOR ALL LACFs PROCESSED AT THIS FACILITY, AND FOR FOREIGN FIRMS, ALL PRODUCTS PROCESSED AND SHIPPED TO THE U.S.? – 108.35(c) No YesNo COMMENTS: 2. HAVE PROCESSES BEEN ESTABLISHED FOR ALL LACFs PROCESSED AT THIS FACILITY? – 113.83 COMMENTS: 3. LIST THE FIRM’S PROCESS AUTHORITIES: WHAT ARE THE PROCESS AUTHORITIES’ CREDENTIALS (KNOWLEDGE, TRAINING AND EXPERIENCE) WITH RETORT SYSTEMS, CONTAINERS, PRODUCTS, ETC.? ARE PROCESS AUTHORITIES ACTIVELY INVOLVED IN EVALUATING TEMPERATURE DISTRIBUTION STUDIES, HEAT PENETRATION STUDIES AND DEVIATIONS ANALYSIS? COMMENTS: 4. ARE THE PROCESS AUTHORITIES THE SAME AS THOSE FILED WITH FDA? COMMENTS: 5. DOES THE FIRM HAVE A PROCESS LETTER OR OTHER PROCESS SOURCE DOCUMENTATION LISTING CRITICAL FACTORS NECESSARY TO CONTROL IN THE ATTAINMENT OF COMMERCIAL STERILITY? COMMENTS: 6. DO CRITICAL FACTORS/LIMITS LISTED IN SOURCE DOCUMENTS MATCH CRITICAL FACTORS/LIMITS FOR SELECTED PRODUCTS AND PROCESSES FILED WITH FDA? NOTE – CRITICAL FACTORS MAY EXIST THAT THE FIRM CONTROLS BUT HAVE NOT BEEN IDENTIFIED IN THE PROCESS FILING AND/OR HAS FAILED TO IDENTIFY AND DOES NOT CONTROL. CRITICAL FACTOR LIMITS RECOMMENDED BY THE PROCESS AUTHORITY SHOULD BE EQUAL TO OR GREATER THAN CRITICAL LIMITS FILED WITH FDA. COMMENTS: Yes. YesNo . No Yes. . .No Yes
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Following Datasheets	UCM071554_1 (7 pages) UCM071562_1 (18 pages) UCM071565_1 (10 pages) UCM071581_1 (9 pages) UCM071587_1 (11 pages) UCM071605_1 (8 pages) UCM071615_1 (11 pages) UCM071640_1 (7 pages) UCM071653_1 (11 pages) UCM071661_1 (11 pages)
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