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FDA establishment 1000305406, Thomasville, Georgia, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 7
Official action indicated: 0
Last inspection ended: Jan 9, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 640.4(f). Arm preparation The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.
Voluntary Action Indicated (VAI)
May 16, 2022
Biologics · Blood and Blood ProductsBiologics · Vaccines and Allergenic Products
None posted
No Action Indicated (NAI)
Jun 22, 2018
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Mar 31, 2016
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Sep 18, 2014
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
May 15, 2012
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Jun 18, 2010
Biologics · Blood and Blood Products
3 cited references
21 CFR 606.20(b). Qualifications of responsible personnel The personnel responsible for the collection, storage, and distribution of blood or blood components are not adequate in training and experience, including professional training as necessary to assure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess.
21 CFR 640.3(f). Donations in less than eight weeks A person served as a source of blood more than once in 8 weeks and was not examined at the time of donation and certified by a physician to be in good health as indicated in part in 21 CFR 640.3(b).
21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection and storage of blood and blood components for homologous transfusion are not always followed.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Thomasville, Georgia, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.