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FDA establishment 1274247, Hyannis, Massachusetts, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 8
Official action indicated: 0
Last inspection ended: Sep 10, 2024
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 630.10(f)(6)(ii). Physical Assessment Determination - Skin Examination Failure to determine that the donor was in good health based on an absence of punctures and scars indicative of injected drugs of abuse on the arms and forearms.
21 CFR 610.41. Donor Deferral Failure to defer a donor who tested reactive by a screening test for evidence of infection due to a relevant transfusion-transmitted infection from future donations of human blood and blood components.
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 processing of blood and blood components for allogeneic transfusion were not always established and followed.
21 CFR 211.110(b). In-process conformity - examination, sample testing Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.
21 CFR 606.160(e)(1). Donor deferral record - each location Failure to maintain at each location a record of all donors found to be ineligible or deferred at that location so that products from such donors are not collected and/or released.
Voluntary Action Indicated (VAI)
Dec 29, 2016
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Oct 23, 2014
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Aug 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 collection and distribution of blood and blood components for homologous transfusion are not always maintained and followed.
21 CFR 606.100(b)(21). Donor notification The standard operating procedure fails to include a written description of the process for follow-up if the initial attempt at donor notification fails.
21 CFR 610.41. Donor Deferral Failure to defer a donor who tested reactive from further donations of human blood and blood components.
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
Hyannis, Massachusetts, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.