Attachment_12_-_OEI_Improvement_Form.pdf

Last Updated: 11/10/2016 Form

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 SOP 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. 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 To Determine if Firm is a Depot (Warehouse Only):

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

25. Interstate:

Percent Received: Percent Shipped:

26. Establishment Type/ Industry Code (Choose applicable information from drop down and additionally document the type/code for all activities):

27. Brief Description of Firm’s Operation:

POINT OF CONTACT INFORMATION

28. Headquarters Inspection Site

29. Point of Contact Name:

30. Title:

31. Phone Number:

32. E-mail Address:

REGISTRATION INFORMATION

33. Registration Required:

Yes No Voluntary

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

Yes No

35. 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 ___________ GDUFA ____________ Medicated Feed (CVM) ___________ Food ___________

Egg (SEG) ___________ Food Canning Establishment (FCE) ___________

RECOMMENDED ACTIONS

36. Program Risk Identifier:

OC FY OEI CFSAN – Designated B-Firm Cleanup

OS FY OEI State – Designated B-Firm Cleanup

OO FY OEI Coordinator-Designated B-Firm Cleanup

37. Recommended Workload Obligation:

Yes No Unknown

38. Recommended Registration Cancellation(s):

39. Operational Status: Operational Seasonal (Start Date: End Date: )

Pre-Production Not OEI Inactive Out of Business

Last Updated: 11/10/2016 Form

40. Recommended Merge FEI Number(s):

41. Other Data Corrections Needed:

42. Additional Notes/Comments:

PREPARER’S INFORMATION

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

45. Phone Number: 46. E-mail:

47. Signature:

48. Date (MM/DD/YYYY):

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

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

51. Phone Number: 52. E-mail:

53. Signature:

54. Date (MM/DD/YYYY):

APPROVING OFFICIAL (OEI Coordinator)

55. Date FMS updated:

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

58. Phone Number: 59. E-mail:

60. Signature:

61. 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.