Imported Products Facility Inspection Checklist

Imported Products Facility Inspection Checklist

Current as of November 7, 2014

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Imported Products Facility Inspection Checklist

The facility must be in production at the time of inspection.NOTE: An updated questionnaire must be submitted any time additional animal origin materials are received, stored, processed, or otherwise handled in the facility.

PLEASE PRINT OR TYPE

1. Name of facility being inspected (include facility number, if applicable):

______.

2. Address (physical location) of facility being inspected:

______

______

______.

3. Address of the facility headquarters if different from above:

______

______

______.

4. Responsible facility representative accompanying the official veterinarian during inspection:

Name: ______

Title:______

Telephone: ______

Facsimile: ______

5. The facility performs or provideswhich of the following (circle all that apply):

• Processing/Manufacturing
• Slaughter
• List ALL the species slaughtered in the facility:

______.

• Packaging
• Closed Container Storage/Warehouse (receives materials in final primary packaging)
• NOTE: If the facility is only a closed container storage/warehouse facility, skip to question 11. To be considered a closed container storage/warehouse facility only, the product cannot be manipulated and must be received and maintained in original primary packaging. This questionnaire must be completed singly for each facility which supplies the storage/warehouse facility with animal origin materials.
• Open Container Storage/Warehouse (receives unpackaged [bulk] materials)
• NOTE: Open container storage/warehouse facilities are those which do not meet the requirements of a closed contain storage/warehouse facility as listed above. This questionnaire must be completed singly for each facility which supplies the storage/warehouse facility with animal origin materials.

6. List all the animal origin ingredients, species of origin, and country(s) of origin in the table below for all animal origin materials received, stored, processed or otherwise handled in this facility AND all animal origin materials for all products produced in the facility. For tallow, specify as greater than or less than 0.15% insoluble impurities as a percentage in weight. (Attach additional sheet if more space is needed.)NOTE: This includes materials which are routinely handled by the facility but may not currently be present as well as finished products not manufactured in the facility.

ANIMAL ORIGIN INGREDIENTS
(e.g. meat-and-bone meal, blood, tallow, offal, egg, milk, gelatin, fish meal, fat, vitamin D3, calcium phosphate derivatives, finished products not manufactured in the facility, etc.) / SPECIES OF ORIGIN
e.g. fish/shellfish, avian, (chicken, turkey, duck, squab), bovine (cow, bison), porcine (pig), ovine (lamb, sheep), caprine (goat), equine (horse), cervid (deer), etc. / COUNTRY OF ORIGIN

During your inspection, verify that the table in question 6 is complete and accurate.

7. ___ YES ___ NO. Was there any evidence that the facility receives, stores, processes, or otherwise handles any animal origin materials not included on the table in question 6? If YES, please include details below (attach additional sheet if more space is needed).

______

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8.___ YES ___ NO ___ N/A.If Vitamin D3 is listed in the table for question 6, were you able to verify the origin as sheep wool grease (lanolin)? Please include details below (attach additional sheet if more space is needed).

______

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9.___ YES ___ NO ___ N/A.If tallow is listed in the table for question 6, were you able to verify the percentage insoluble impurities as less than 0.15% by weight through a certificate of analysis or other laboratory report? If NO, please include details below (attach additional sheet if more space is needed).

______

______.

10. ___ N/A.If bovine gelatin is listed in the table for question 6, verify that it was derived from (circle all that apply):

• Bones
• Hides/skins

11. List all the facilities which supply thefacility being inspected with animal origin ingredients. (Attach additional sheet if more space is needed.)

NAME OF FACILITY / ADDRESS OF FACILITY
(including country) / CONTACT INFORMATION

12. ___ YES ___ NO. Was there any evidence that the facility receives, stores, processes, or otherwise handles animal origin materials from any supplier not included on the table in question 11? If YES, please include details below (attach additional sheet if more space is needed).

______

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13. ___ YES ___ NO. When you randomly selected several animal origin materials in the facility, was the management able to demonstrate that the materials were supplied by the facility/facilities listed on the table in question 11? If NO, please include details below (attach additional sheet if more space is needed).

______

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14. Please identify how you were able to determine the country of origin for each material imported from a foreign supplier (circle all that apply):

• Foreign health certificate
• Commercial document for transport of animal by-products not intended for human consumption in accordance with EC no 1069/2009
• Other

If OTHER, please describe below (attach additional sheet if more space is needed).

______

______.

15. ___ YES ___ NO ___ N/A. For any imported rendered materials (e.g., meals) or hydrolysates (e.g., digests), is the supplying facility dedicated to non-ruminant species?If NO, please describe how the inspected facility verifies that the supplying facility maintains separation of species (attach additional sheet if more space is needed).

______

______.

16. ___ YES ___ NO ___ N/A. For any imported ruminant material, was the management able to providea foreign health certificate, a commercial document for transport of animal by-products not intended for human consumption in accordance with EC no 1069/2009, or other documentationverifying the country from which the materials originated? If NO, please include details below (attach additional sheet if more space is needed).

______

______.

17. ___ YES ___ NO ___ N/A. If the facility receives, stores, processes, or otherwise handles ovine and/or caprine materials, does the facility have a written plan in place to record, monitor, and verify that the ovine/caprine origin materials were not supplied by countries ineligible3 to exportovine/caprine materials to the United States? If NO, please include details below (attach additional sheet if more space is needed).

______

______.

18. ___ YES ___ NO ___ N/A. If the facility receives, stores, processes, or otherwise handles ovine and/or caprine materials, does the facility have a written plan in place to identify, respond, and correct in the event that ovine/caprine origin materials were supplied by countries ineligible to exportovine/caprine materials to the United States? If NO, please include details below (attach additional sheet if more space is needed).

______

______.

19. The following questions pertain to cross contamination risk from materials ineligible for export to the US. Ineligible materials include:

• ovine/caprine from countries listed in footnote3,
• bovinemeat-and-bone meal and greaves from countries recognized by APHIS as controlled1 or undetermined risk2,
• Specified Risk Materials (SRMs)4,
• Mechanically Separated Meat from the skull and vertebral column of bovines 30 months of age and older(controlled risk countries)andolder than 12 months of age (undetermined risk countries).

a. ___ YES ___ NO ___ N/A. Does the facility maintain dedicated processing rooms for product eligible for export to the US?

b. ___ YES ___ NO ___ N/A. Does the facility maintain dedicated processing equipment (e.g. lines, machinery, and utensils) for product eligible for export to the US?

c. ___ YES ___ NO ___ N/A. Does the facility maintain dedicated storage rooms for product eligible for export to the US?

d. ___ YES ___ NO ___ N/A. Does the facility maintain dedicated employees for product eligible for export to the US?

e. ___ YES ___ NO ___ N/A. Does the facility maintain appropriate documentation (e.g. signs and labels) and employee training to ensure product eligible for export to the US does not come in contact with product ineligible for export to the US?

f. ___ YES ___ NO ___ N/A. For shipments of bulk materials, does the facility use dedicated trucks?

1 Countries recognized by APHIS as Controlled Risk:Bulgaria, Canada, Costa Rica, Croatia, Cyprus, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Latvia, Lichtenstein, Lithuania, Luxembourg, Malta, Mexico, Nicaragua, Poland, Portugal, Republic of Korea, Slovak Republic, Spain, Switzerland, Taiwan, and the United Kingdom

2 Countries recognized by APHIS as Undetermined Risk: all countries excluding those listed above and Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Denmark, Finland, Iceland, Israel, Italy, Japan, the Netherlands, New Zealand, Norway, Panama, Paraguay, Peru, Singapore, Slovenia, Sweden, and Uruguay

3 Albania; Andorra; Austria; Belgium; Bosnia and Herzegovina; Bulgaria; Canada; Croatia; Czech Republic; Denmark; Federal Republic of Yugoslavia; Former Yugoslav Republic of Macedonia; Finland; France; Germany; Greece; Hungary; Republic of Ireland; Israel; Italy; Japan; Liechtenstein; Luxembourg; Monaco; Netherlands; Norway; Oman; Poland; Portugal; Romania; Republic of San Marino; Slovakia; Slovenia; Spain; Sweden; Switzerland; or the United Kingdom (includes Great Britain (England, Scotland, Wales, Isle of Man), Northern Ireland, and the Falklands)

4 SRMs: brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia from bovines 30 months of age and older (controlled risk countries) and older than 12 months of age (undetermined risk countries), and the distal ileum of the small intestine and the tonsils from all bovines

If NO to any part of question 19, please explain how the facility prevents cross contamination of product eligible for export to the US with product ineligible for export to the US (i.e. monitoring proper use of hygiene protocols such as hand washing, use of gloves, aprons, disinfection stations, using signs and labels, cleaning and sanitizing trucks, etc.). Attach additional sheet if more space is needed.

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20. Please select materials from at least 3 different lots when reviewing records.

a. ___ YES ___ NO. When reviewing the facility’s records were you able to verify the records were consistent with the information provided on the tables in questions 6 and 11? If NO, please include details below (attach additional sheet if more space is needed).

______

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b. ___ YES ___ NO. When selecting lots from the facility’s finished product storage area, was the facility able to produce records tracking that lot and individual ingredient(s) back to the incoming raw material? If NO, please include details below (attach additional sheet if more space is needed).

______

______.

21. ___ YES ___ NO. Is the equipment maintained in good condition (i.e. free of cracks, pitting, rust, or other defects that could affect cleaning and sanitizing procedures) so as to be easily cleaned? If NO, please include details below (attach additional sheet if more space is needed).

______

______.

22. ___ YES ___ NO. Is the building maintained in a sound condition (i.e. no leaks, no standing water, no evidence of pests/rodents, well maintained floors, ceilings, and walls)? If NO, please include details below (attach additional sheet if more space is needed).

______

______.

23. Please explain how the facility maintains sanitation and prevents adulteration of product intended for export to the United States (i.e. monitoring proper use of hygiene protocols such as hand washing, use of gloves, aprons, disinfection stations, using signs and labels, cleaning and sanitizing trucks, etc.). Attach additional sheet if more space is needed.

______

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24. ___ YES ___ NO. Were there any findings during the course of the inspection that raise a concern as towhether the facility’s measures are adequate to maintain basic sanitation, product identity and integrity, and prevent adulteration of product intended for export to the United States? If YES, please include details below (attach additional sheet if more space is needed).

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Signature of responsible facility representative

______

Printed name of responsible facility representative

______

Title of responsible facility representativeDate

______SEAL

Signature of official government veterinarian

______

Printed name of official government veterinarian

______

Title of official government veterinarianDate

______

Phone number/email of official government veterinarian

Recommendation of APHIS/VS Staff Veterinarian (circle one):

APPROVEDDISAPPROVED

______

Signature of APHIS/VS Staff Veterinarian/Date

Current as of November 7, 2014

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