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FDA establishment 1274643, Concord, Massachusetts, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 10
Official action indicated: 0
Last inspection ended: Aug 6, 2025
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 storage and distribution, quality control and general records.
21 CFR 606.100(b). SOPs for investigations, records Written standard operating procedures for all steps in the investigation of product deviations under the regulations and recordkeeping related to current good manufacturing practice and other applicable requirements and standards were not established, maintained, followed and available to personnel in the areas where procedures were performed.
21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the compatibility testing, storage and distribution of blood and blood components for allogeneic transfusion were not always established, maintained and followed.
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 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the processing, storage and distribution of each unit of blood and blood components so that all steps can be clearly traced.
Voluntary Action Indicated (VAI)
Mar 30, 2023
Biologics · Vaccines and Allergenic ProductsBiologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Feb 4, 2019
Biologics · Blood and Blood Products
1 cited reference
21 CFR 610.53(b). Dating periods for licensed biological products Failure to assign dating periods in accordance with 21 CFR 610.53 or as approved by CBER.
Voluntary Action Indicated (VAI)
Apr 13, 2017
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Jan 13, 2015
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 storage of blood and blood components for homologous transfusion and autologous transfusion and further manufacturing purposes are not always followed .
21 CFR 640.3(a)(1). Donor suitability procedures not followed Failure to follow standard procedures and methods for determining the suitability of a donor as a source of blood.
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.
Voluntary Action Indicated (VAI)
Mar 13, 2013
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Jun 1, 2012
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Nov 18, 2011
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Jul 19, 2010
Biologics · Blood and Blood Products
2 cited references
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.
21 CFR 606.170(a). Adverse Reaction - Investigations A thorough investigation of each reported adverse reaction was not made.
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
Concord, Massachusetts, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.