Staten Island University Hospital Northwell Health
FDA establishment 2473418, Staten Island, New York, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection, processing, storage, and distribution of blood and blood components for homologous transfusion, autologous transfusion, and further manufacturing purposes are not always maintained and followed.
21 CFR 630.40(c). Notification w/in 8 weeks Failure to make reasonable attempts to notify the donor within 8 weeks after determining that the donor is deferred or determined not to be suitable for donation.
21 CFR 606.160(a)(1). Legibility and indelibility Records are illegible and not indelible.
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.
Voluntary Action Indicated (VAI)
Nov 19, 2012
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Dec 14, 2011
Biologics · Blood and Blood Products
3 cited references
21 CFR 606.160(a)(1). Legibility and indelibility Records are illegible.
21 CFR 606.100(b)(6). Methods of component preparation The standard operating procedure fails to include written descriptions of the methods for component preparation, including any time restrictions for specific steps in processing.
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
Voluntary Action Indicated (VAI)
Mar 4, 2010
Biologics · Blood and Blood Products
4 cited references
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing.
21 CFR 211.194(a)(8). Second person sign off Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
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 homologous transfusion, autologous transfusion, and further manufacturing purposes are not always maintained and followed.
21 CFR 211.194(a)(7). Signatures and dates--person who performs test Laboratory records do not include the initials or signature of the person who performs each test and the date(s) the tests were performed.
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