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FDA establishment 3001451318, Gainesville, 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: Aug 12, 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 606.40(a)(1). Provide space for examination Failure to provide adequate space for private and accurate examinations of individuals to determine their eligibility as blood donors.
21 CFR 606.60(b). Equipment calibration frequency Equipment used in the collection and processing of blood and blood components is not observed, standardized and calibrated with at least the frequency required.
Voluntary Action Indicated (VAI)
Apr 11, 2019
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Feb 3, 2017
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Apr 24, 2015
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Mar 27, 2013
Biologics · Human Cellular, Tissue, and Gene TherapiesBiologics · Blood and Blood Products
3 cited references
21 CFR 606.160(b). Required records Failure to maintain storage and distribution records.
21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection of blood and blood components for further manufacturing purposes are not always followed.
21 CFR 640.4(h). Storage temperatures after collection After collection, blood is not immediately stored at a temperature between 1 and 6 degrees Celsius.
No Action Indicated (NAI)
Apr 11, 2011
Biologics · Blood and Blood ProductsBiologics · Human Cellular, Tissue, and Gene Therapies
2 cited references
21 CFR 606.170(a). Adverse Reaction - Investigations A thorough investigation of each reported adverse reaction was not made.
21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection of blood and blood components for homologous transfusion and autologous 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
Gainesville, Georgia, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.