Industry Guidance of Medical Products for Defense Logistics Agency Contacts
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Office of Regulatory Affairs
Office of Information Systems Management
Division of Systems Solution
Enforcement Systems Branch
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 |
754CK8 |
|
Baltimore District |
6000 Metro Drive, Suite 101, Baltimore, MD 21215 |
753354 |
|
Chicago District |
550 West Jackson Blvd. Suite 1500, Chicago, IL 60661 |
7551FF |
|
Cincinnati District |
6751 Steger Drive, Cincinnati, OH 45237 |
7555AX |
|
Dallas District |
4040 N Central Expressway Suite 300, Dallas, TX 75204 |
757M88 |
|
Denver District |
Box 25087 DFC Bldg. 20 West 6th Avenue & Kipling Street, Denver, CO 80225 |
7582RS |
|
Detroit District |
300 River Place Suite 5900, Detroit, MI 48207 |
755002 |
|
Florida District |
555 Winderley Place Suite 200, Maitland, FL 32751 |
7542KS |
|
Kansas City District |
11630 West 80th Street, Lenexa, KS 66285 |
7562BQ |
|
Los Angeles District |
19701 Fairchild, Irvine, CA 92612 |
759105 |
|
Minneapolis District |
212 Third Avenue South, Minneapolis, MN 55401 |
755503 |
|
New England District |
One Montvale Avenue, Stoneham, MA 02180 |
751305 |
|
New Jersey District |
Waterview Corporate Center 10 Waterview Blvd. 3rd floor, Parsippany, NJ 07054 |
7522AV |
|
New Orleans District |
404 BNA Drive, Building 200, Suite 500, Nashville, TN 3721 |
7547AV |
|
New York District |
158-15 Liberty Avenue, Jamaica, NY 11423 |
752380 |
|
Philadelphia District |
US Customshouse 2nd & Chestnut Streets Room 900, Philadelphia, PA 19106 |
753639 |
|
San Francisco District |
1431 Harbor Bay Parkway, Alameda, CA 94502 |
759107 |
|
San Juan District |
466 Fernandez Juncos Avenue Puerto De Tierra, San Jaun, Puerto Rico 00901 |
75F3CW |
|
Seattle District |
22201 23rd Drive SE, Bothell, WA 98021 |
7505LC |
Resources
-
WAWF Help Desk Support
WAWF@dla.mil -
Vendors must utilize DLA Distribution 1-800-456-5507 or http://www.dla.mil/Portals/104/Documents/LandAndMaritime/ZA/LM_VSMUSERGUIDE20143_151028.pdf Vendor Shipment Module Application to obtain the shipping address and transportation instructions.
-
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 -
Industry Guidance of Medical Products for Defense Logistics
https://www.fda.gov/iceci/inspections/inspectionguides/inspectiontechnicalguides/ucm513121.htm