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Industry Guidance of Medical Products for Defense Logistics Agency Contacts

Industry Guidance of Medical Products for Defense Logistics Agency Contacts

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DEPT. OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
*ORA/OEIO/DCS/ESB*
Date: 7/25/16 Number: 53
Related Program Areas:Government Wide Quality Assurance Program
 

ITG SUBJECT: INDUSTRY GUIDANCE OF MEDICAL PRODUCTS FOR DEFENSE LOGISTICS AGENCY CONTRACTS

FDA is responsible for protecting the public health by assuring the safety and efficacy of drugs, medical devices, and biologic products.

A Memorandum of Understanding (MOU) between the Defense Logistics Agency (DLA) and the Food and Drug Administration (FDA) gave FDA the role to provide quality assurance support for DLA’s centrally managed contracts for drugs, medical devices, and biologics as defined by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The MOU also states FDA will be responsible for determining medical products offered for delivery are in accordance with the contract requirements, and for signing the acceptance document when a source inspection is required.

DLA Responsibilities

Contracts received by DLA to conduct a source inspection will be addressed to the Government Wide Quality Assurance (GWQAP) staff. DLA confirms that the contract stipulations are in order and reviews the source inspection request to ensure the product is regulated by FDA.

Investigator Responsibilities

The FDA District Field Office ensures the appropriate and efficient use of FDA resources for accomplishing work assignments issued by the GWQAP staff. Each work assignment clearly states what is needed to accomplish the task of conducting a source inspection, how, when, and to whom the results are to be reported.

When conducting a source inspection, the lot numbers of the products identified in the contract are to be reviewed for adherence to the contract and compliance with GMPs, if applicable; by the FDA investigator or document review document review for field examination.

The District Field Office will inform the GWQAP staff of the decision to endorse or not the DLA Receiving Report based on the completed inspection or current profile class code statuses to determine if there are any GMP deficiencies.

Any contract deficiencies are grounds to not accept the Receiving Report and a meeting between the GWQAP staff and DLA is held to determine if the contract deficiencies warrant non-acceptance. 

Depending on the findings of the District Field Office and discussion of the results with DLA, the GWQAP staff will either endorse the Receiving Report or enter the reasons for non-acceptance, such as “GMP deficiencies” or “contractual deficiencies” in the  DLA’s Invoicing, Receipt, Acceptance, and Property Transfer (iRAPT) database system.

Vendor Responsibilities

It is the responsibility of the vendor to ensure product for examination is available at the time of inspection.  If the activity a vendor performs is subject to Good Manufacturing Practices (GMP) regulations, a GMP inspection may be conducted in conjunction with the source inspection.  Vendor activities that may necessitate a GMP inspection include:

  • Manufacturers
  • Remanufacturers
  • Reporcessors
  • Packer/Rrepackers
  • Labelers/Relabelers
  • Contract Sterilizers
  • Control Testing Laboratories
  • Assemblers of Medical Device Kits
  • Specification Developers; the vendor is subject to GMP regulations. 

If the vendor falls under any of the above categories, a GMP inspection will be conducted in addition to the source inspection.

Once the source inspection has been conducted, vendor upload the receiving report into the DLA iRAPT system for payment and an automated generated email will be sent to the GWQAP staff that the receiving report is ready for at which time the GWQAP staff will either accept or not accept the report.

Full Invoicing Guidance

WAWF Invoicing Instructions

  • Logon to WAWF via https://wawf.eb.mil.
  • Click the Vendor link on the left side of the screen.
  • Click on "Create New Document".
  • Enter contract number (and/or delivery order number).
  • Select applicable vendor CAGE code from dropdown box.
  • Click Next.
  • Enter the Pay DODAAC in the "Pay Official" box. This DODAAC is SL4701 or the noted DODAAC contained in block 15 of each individual purchase or delivery order.
  • Select (click) on "Invoice and Receiving Report" combo.
  • In the "Inspection" and "Acceptance" drop down fields, select "OTHER" for both categories.
  • In the "Accept at Other DODAAC" field, enter the assigned FDA FAC Code, which is the FDA Agency performing the I & A inspection.  
  • When the Receiving Report is complete, click "Submit" button.

Department of Defense Activity Address Code (DODAAC) 
 


District Office

DODAAC

Atlanta District

754CK8

Baltimore District

753354

Chicago District

7551FF

Cincinnati District

7555AX

Dallas District

757M88

Denver District

7582RS

Detroit District

755002

Florida District

7542KS

Kansas City District

7562BQ

Los Angeles District

759105

Minneapolis District

755503

New England District

751305

New Jersey District

7522AV

New Orleans District

7547AV

New York District

752380

Philadelphia District

753639

San Francisco District

759107

San Juan District

75F3CW

Seattle District

7505LC

Vendors must utilize DLA Distribution 1-800-456-5507 or http://www.dla.mil/Portals/104/Documents/LandAndMaritime/ZA/LM_VSMUSERGUIDE20143_151028.pdfVendor Shipment Module Application to obtain the shipping address and transportation instructions.

Resources

WAWF Help Desk Support WAWF@dla.mil

Memorandum of Understanding Between the Department of Defense and The Food and Drug Administration  http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm494075.htm

Investigations Operations Manual, section 5-14 Profiling a Firm’s CGMP/QS Compliance Status
http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM127451.pdf
 

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