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FDA establishment 1276528, Worcester, Massachusetts, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 9
Official action indicated: 0
Last inspection ended: Apr 8, 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. Clean & orderly Failure to maintain facilities in a clean and orderly manner.
Voluntary Action Indicated (VAI)
Oct 28, 2022
Biologics · Blood and Blood ProductsBiologics · Vaccines and Allergenic Products
None posted
No Action Indicated (NAI)
Oct 28, 2019
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Feb 12, 2018
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Jun 3, 2016
Biologics · Blood and Blood Products
2 cited references
21 CFR 606.65(e). Following manufacturer's instructions Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer.
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 and further manufacturing purposes were not always followed.
Voluntary Action Indicated (VAI)
Jun 26, 2014
Biologics · Blood and Blood Products
1 cited reference
21 CFR 640.25(a). Storage temps./agitation Failure to store platelets immediately after resuspension at 20 to 24 degrees Celsius with continuous gentle agitation.
Voluntary Action Indicated (VAI)
Dec 20, 2012
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Dec 2, 2011
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 collection, compatibility testing, storage, and distribution of blood and blood components for homologous transfusion and autologous transfusion are not always maintained and followed.
Voluntary Action Indicated (VAI)
Nov 30, 2009
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 homologous transfusion are not always followed.
21 CFR 606.160(a)(1). Person performing, test results, interpretation Records fail to identify the person performing the work and be as detailed as necessary so as to provide a complete history of the work performed.
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Worcester, Massachusetts, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.