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.
FDA establishment 1873407, Traverse City, Michigan, 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 7, 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 606.160(b). Required records Failure to maintain processing, storage and distribution, quality control and general records.
21 CFR 606.160(a)(1). Person performing, test results, interpretation Records fail to identify the person performing the work so as to provide a complete history of the work performed.
21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the processing, storage and distribution of blood and blood components for allogeneic transfusion were not always established, maintained and followed.
21 CFR 610.47(b)(3). Notify MD, Legal Rep, Relative of Trans Recipient[Consignee] Failure to notify physician of record of a recipient, who received previous collections of blood and blood components at increased risk of transmitting HCV infection, of the need for recipient HCV testing and counseling.
Voluntary Action Indicated (VAI)
Aug 3, 2023
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Aug 31, 2018
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Aug 12, 2016
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Jul 15, 2014
Biologics · Blood and Blood Products
1 cited reference
21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the processing and distribution of blood and blood components for homologous transfusion are not always followed.
Voluntary Action Indicated (VAI)
Jun 14, 2012
Biologics · Blood and Blood Products
3 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 processing and distribution of blood and blood components for homologous transfusion, autologous transfusion, and further manufacturing purposes are not always maintained and followed.
21 CFR 606.160(a)(1). Legibility and indelibility Records are illegible.
21 CFR 606.160(b). Required records Failure to maintain storage and distribution, quality control, and general records.
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
Traverse City, Michigan, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.