Company
United StatesThe American National Red Cross Diagnostic Manufacturing Division, Gaithersburg, MD – FDA Inspections
Inspection records and compliance data for The American National Red Cross Diagnostic Manufacturing Division in Gaithersburg, Maryland. 8 FDA inspections on record, 1 Form 483, last inspected July 10, 2026.
Company Profile
This profile covers The American National Red Cross Diagnostic Manufacturing Division based in Gaithersburg, Maryland, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 4
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected December 4, 2009. Last inspected July 10, 2026.
Most cited issue areas
- Identification of actions needed1 inspection
- Minor changes to an approved application1 inspection
- Moderate changes to an approved application1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 10, 2026 | NAI | · Blood and Blood Products | 1326648 |
| February 13, 2024 | NAI | Biologics · Blood and Blood Products | 1231137 |
| April 27, 2018 | VAI | Biologics · Blood and Blood Products | 1058813 |
| June 15, 2016 | NAI | Biologics · Blood and Blood Products | 991584 |
| August 29, 2014 | VAI | Biologics · Blood and Blood Products | 898271 |
| November 4, 2011 | VAI | Biologics, Medical Devices & Rad Health · Blood and Blood Products | 752096 |
| August 19, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 676159 |
| December 4, 2009 | VAI | Biologics · Blood and Blood Products | 636469 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
The American National Red Cross Diagnostic Manufacturing Division
FEI Number
1177732
Address
9319 Gaither Rd, Gaithersburg, Maryland 20877, United States
Country
United States
ID: 1a2397ed-fbee-411b-be4d-05f023c63b65