Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
21 CFR 606.100(c). Thorough investigations Failure to perform a thorough investigation of an unexplained discrepancy.
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 allogeneic transfusion were not always followed.
21 CFR 606.171. Biological product deviation report Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
21 CFR 606.20(b). Qualifications of responsible personnel The personnel responsible for the collection 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.
Voluntary Action Indicated (VAI)
Jul 1, 2022
Biologics · Blood and Blood ProductsBiologics · Vaccines and Allergenic Products
1 cited reference
21 CFR 606.100(c). Thorough investigations Failure to perform a thorough investigation of an unexplained discrepancy.
Voluntary Action Indicated (VAI)
Jan 12, 2018
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Feb 12, 2016
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Sep 17, 2014
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Apr 5, 2012
Biologics · Blood and Blood Products
2 cited references
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 606.40. Clean & orderly Failure to maintain facilities in a clean and orderly manner.
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
Bradenton, Florida, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.