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FDA establishment 2370420, New Orleans, Louisiana, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 7
Official action indicated: 0
Last inspection ended: Oct 5, 2026
Warning letters: 0
Recalls since 2016: 5
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 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection, processing, compatibility testing, storage and distribution of blood and blood components for allogeneic transfusion were not always followed.
21 CFR 600.14(c). When to report Biological product deviations were not reported within the 45 calendar day timeframe.
Voluntary Action Indicated (VAI)
Mar 31, 2022
Biologics · Vaccines and Allergenic ProductsBiologics · Blood and Blood Products
3 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 606.40(a)(1). Provide space for examination Failure to provide adequate space for private examinations of individuals to determine their eligibility as blood donors.
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 followed.
Voluntary Action Indicated (VAI)
May 4, 2018
Biologics · Blood and Blood Products
8 cited references
21 CFR 600.15. Blood & Blood Components Failure to maintain temperatures during shipment of Whole Blood as required.
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 606.171. Biological product deviation report Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the processing of blood and blood components for allogeneic transfusion and further manufacturing purposes were not always followed.
21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the collection, processing, storage and distribution of each unit of blood and blood components so that all steps can be clearly traced.
21 CFR 640.25(b). Quality control Failure to test each month (of manufacture) four units prepared from different donors at the end of the storage period for platelet count, pH of not less than 6.0 measured at the storage temperature of the unit and actual plasma volume.
21 CFR 606.100(c). Thorough investigations Failure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy and a failure of a lot or unit to meet any of its specifications.
21 CFR 606.40(a)(1). Provide space for examination Failure to provide adequate space for private examinations of individuals to determine their eligibility as blood donors.
Voluntary Action Indicated (VAI)
Nov 3, 2015
Biologics · Blood and Blood Products
4 cited references
21 CFR 606.160(a)(1). Legibility and indelibility Records are not indelible.
21 CFR 630.40(a). Notification Failure to make reasonable attempts to notify a donor who has been deferred based on the results of tests for evidence of communicable disease agent(s).
21 CFR 606.171. Biological product deviation report Failure to submit a biological product deviation report.
21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the compatibility testing of each unit of blood and blood components so that all steps can be clearly traced.
Voluntary Action Indicated (VAI)
Aug 19, 2013
Biologics · Blood and Blood Products
None posted
Voluntary Action Indicated (VAI)
Jun 17, 2011
Biologics · Blood and Blood Products
3 cited references
21 CFR 606.170(a). Adverse Reaction - Investigations A thorough investigation of each reported adverse reaction was not made.
21 CFR 606.171. Biological product deviation report Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the collection of each unit of blood and blood components so that all steps can be clearly traced.
Voluntary Action Indicated (VAI)
Recalls
5 drug, device and biologic recalls since 2016, newest first; 0 Class I
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
New Orleans, Louisiana, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.