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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION NOTE:

INSPECTION SUMMARY EQUIPMENT EVALUATION

The items marked below identify deficiencies in operations or facilities which must be corrected within a reasonable time period or by such date as may be specified by the regulatory authority. Failure to comply with any time limits for correction specified in reference to this notice may result in cessation of acceptability of your operations, service or product for use on or by interstate conveyances.
ESTABLISHMENT NAME INSPECTION DATE FEI NO.

OWNER/OPERATOR AND ADDRESS

CLASSIFICATION RECOMMENDED (Check One) APPROVED PROVISIONAL (Expiration Date) REPORT PREPARED BY (Name and Title)

)

NOT APPROVED

LOCAL OFFICE

NAME/TITLE/ORGANIZATION REQUESTING INVESTIGATION HOME OFFICE

NAME AND ADDRESS OF MANUFACTURER

NAME AND TITLE OF CONTACT

EQUIPMENT INFORMATION TRADE NAME AND MODEL NUMBER

DESCRIPTION AND SPECIFIC USE OF EQUIPMENT:

PROTOTYPE

PRODUCTION

IN USE

OTHER

ACCEPTANCE BY OTHER AGENCIES, ORGANIZATIONS

FOOD-CONTACT SURFACE MATERIALS AND "FOOD ADDITIVE" STATUS

IDENTIFICATION OF SIGNIFICANT COMPONENT PARTS

FORM FDA 2591 (8/01)

PREVIOUS EDITION IS OBSOLETE.

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Created by: PSC Media Arts (301) 443-2454 XFT

AREAS OF EQUIPMENT DEFICIENCIES INDICATED BY "X" PRODUCT CONTACT SURFACES 1 2 3 4 5 6 7 8 9 10 11 Design Construction Materials NON-PRODUCT CONTACT SURFACES Design Construction Materials JOINTS, SEAMS, AND OPENINGS Design Construction PLUMBING Cross-Connections Water Treatment Waste Water 18 19 20 21 22 23 24 25 26 Appurtenances Design Construction Interfaces Manuals, Instructions Operations General Maintenance Sanitary Maintenance Other 12 13 14 15 16 17 Tests Adequate Design Thermometers Insulation Refrigeration Temperatures MISCELLANEOUS TEMPERATURE CONTROL

REPORT OF FINDINGS AND ACTION TAKEN

REMARKS

FORM FDA 2591 (8/01)

PREVIOUS EDITION IS OBSOLETE.

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