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Industry Guidance of Medical Products for Defense Logistics Agency Contacts

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Food and Drug Administration
Office of Regulatory Affairs
Office of Information Systems Management
Division of Systems Solution
Enforcement Systems Branch
Date: 08/28/2020 
Related Program Areas:Government Wide Quality Assurance Program

Industry Guidance of Medical Products for Defense Logistics

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/Repackers
  • 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.
  • 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 Address AAC

Atlanta District

60 Eighth Street NE, Atlanta, GA  30309


Baltimore District

6000 Metro Drive, Suite 101, Baltimore, MD 21215


Chicago District

550 West Jackson Blvd. Suite 1500, Chicago, IL 60661


Cincinnati District

6751 Steger Drive, Cincinnati, OH  45237


Dallas District

4040 N Central Expressway Suite 300, Dallas, TX 75204


Denver District

Box 25087 DFC Bldg. 20 West 6th Avenue & Kipling Street, Denver, CO  80225


Detroit District

300 River Place Suite 5900, Detroit, MI  48207


Florida District

555 Winderley Place Suite 200, Maitland, FL  32751


Kansas City District

11630 West 80th Street, Lenexa, KS 66285


Los Angeles District

19701 Fairchild, Irvine, CA  92612


Minneapolis District

212 Third Avenue South, Minneapolis, MN 55401


New England District

One Montvale Avenue, Stoneham, MA  02180


New Jersey District

Waterview Corporate Center 10 Waterview Blvd. 3rd floor, Parsippany, NJ 07054   


New Orleans District

404 BNA Drive, Building 200, Suite 500, Nashville, TN 3721


New York District

158-15 Liberty Avenue, Jamaica, NY 11423


Philadelphia District

US Customshouse 2nd & Chestnut Streets Room 900, Philadelphia, PA 19106


San Francisco District   

1431 Harbor Bay Parkway, Alameda, CA  94502


San Juan District

466 Fernandez Juncos Avenue Puerto De Tierra, San Jaun, Puerto Rico 00901


Seattle District

22201 23rd Drive SE, Bothell, WA 98021



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