Attachment_26.pdf

Last Updated: 8/5/2015 Form DRAFT

DEPARTMENT OF HEALTH AND HUMAN SERVICES

U.S. Food and Drug Administration Office of Regulatory Affairs

Official Establishment Inventory (OEI) Data Collection Form Instructions: Please fill out the form in its entirety. See FMD 130 for definitions, establishment types, industry codes.

FIRM INFORMATION

1. FEI Number: 2. DUNS Number:

3. Firm’s Legal Name: 4. Doing Business As (DBA):

5. Firm’s Physical Address:

6. City: 7. State: 8. Zip Code: 9. County:

10. Firm’s Mailing Address:

11. City:

12. State: 13. Zip Code: 14. County:

15. Website: 16. Business Telephone Number:

17. FAX Number:

18. Legal Status Firm:

Corporation LLC LP

Partnership Owner Government Entity

19. Establishment Size: 20. Is this firm a dual jurisdiction (DJE) with the FDA and USDA/FSIS?

Yes No

21. Percent Retail :

22. Percent Wholesale (Total % of firm products that are sold wholesale – food firms only (include intrastate and interstate):

23. Product Turn Around Time (Warehouse Only):

24. Hours of Operation (If seasonal include months):

25. Interstate:

Percent Received: Percent Shipped:

26. Establishment Type:

27. Industry Code:

28. Brief Description of Firm’s Operation:

POINT OF CONTACT INFORMATION

29. Headquarters Inspection Site

30. Point of Contact Name:

31. Title:

32. Phone Number:

33. E-mail Address:

REGISTRATION INFORMATION

34. Registration Required:

Yes No Voluntary

35. Firm Registered (Data from a Center registration system)?

Yes No

36. Registration Type(s) / most recent registration date (s) (MM/DD/YYYY) from a Center registration system:

Biologics: Blood ___________ Biologics: Human Tissue ___________ Device ___________ Drug: CVM ___________

Drug: Human ___________ Egg (SEG) ___________ Food ___________ GDUFA ____________

LACF ___________ Medicated Feed (CVM) ___________

RECOMMENDED ACTIONS

37. Program Risk Identifier:

OC 16 FY 16 OEI CFSAN – Designated B-Firm Cleanup

OS 16 FY 16 OEI State – Designated B-Firm Cleanup

OO 16 FY 16 OEI Coordinator-Designated B-Firm Cleanup

38. Recommended Workload Obligation:

Yes No Unknown

39. Recommended Registration Cancellation:

40. Operational Status: Operational Seasonal Pre-Production Not OEI Inactive Out of Business

Last Updated: 8/5/2015 Form DRAFT

41. Recommended Merge FEI Number(s):

42. Other Data Corrections Needed:

43. Additional Notes/Comments:

PREPARER’S INFORMATION

44. Name: 45. Office/Division/District:

46. Phone Number: 47. E-mail:

48. Signature:

49. Date (MM/DD/YYYY):

RECOMMENDING OFFICIAL (Supervisor, Contracting Official, State Liaison, or other Management)

50. Name: 51. Office/Division/District:

52. Phone Number: 53. E-mail:

54. Signature:

55. Date (MM/DD/YYYY):

APPROVING OFFICIAL (OEI Coordinator) 56: Date FMS updated:

57. Name: 58. Office/Division/District:

59. Phone Number: 60. E-mail:

61. Signature:

62. Date (MM/DD/YYYY):

NOTE: Forms may be stored in the physical firm jackets (if one exists), in the district’s electronic file, or the OEI coordinator’s file.