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FDA establishment 2572105, Erie, Pennsylvania, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 6
Official action indicated: 0
Last inspection ended: Aug 23, 2024
Warning letters: 0
Recalls since 2016: 13
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(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the storage of each unit of blood and blood components so that all steps can be clearly traced.
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 were not always.
21 CFR 606.100(c). Thorough investigations Failure to perform a thorough investigation of an unexplained discrepancy.
Voluntary Action Indicated (VAI)
Jun 10, 2015
Biologics · Blood and Blood Products
3 cited references
21 CFR 211.68(a). Written calibration / inspection records not kept Records of the inspections of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
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.
21 CFR 606.60(a). Equipment observed, standardized, calibrated Equipment used in the collection of blood and blood components is not calibrated on a regularly scheduled basis as prescribed in the SOP Manual.
Voluntary Action Indicated (VAI)
Apr 26, 2013
Biologics · Blood and Blood Products
7 cited references
21 CFR 606.60(a). Equipment observed, standardized, calibrated Equipment used in the collection and processing of blood and blood components is not observed and calibrated on a regularly scheduled basis as prescribed in the SOP Manual.
21 CFR 640.5(e). Testing - inspection Failure to visually inspect blood during storage and immediately prior to issue for abnormal color, physical appearance, or indication or suspicion of microbial contamination.
21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the processing and storage of each unit of blood and blood components so that all steps can be clearly traced.
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 are not always maintained and followed.
21 CFR 606.100(c). Thorough investigations Failure to perform a thorough investigation of an unexplained discrepancy.
21 CFR 211.100(a). Changes to Procedures Not Reviewed, Approved Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit.
21 CFR 640.3(a). Donor suitability by means of medical history Failure to always determine donor suitability on the day of collection by means of test for hemoglobin level.
Voluntary Action Indicated (VAI)
Aug 25, 2011
Biologics · Blood and Blood ProductsBiologics · Human Cellular, Tissue, and Gene Therapies
6 cited references
21 CFR 606.20(b). Qualifications of responsible personnel The personnel responsible for the collection, processing, compatibility testing, storage, and distribution of blood or blood components are not adequate in training and experience, including professional training as necessary to assure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess.
21 CFR 606.170(a). Adverse reaction - Maintenance of Reports Failure to maintain reports of complaints of adverse reactions regarding each unit of blood or blood product arising as a result of blood collection.
21 CFR 211.22(a). Authority lacking to review records, investigate errors The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
21 CFR 606.60(b). Equipment calibration frequency Equipment used in the processing of blood and blood components is not observed, standardized and calibrated with at least the frequency required.
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 and fully followed.
21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the processing, compatibility testing, and storage of each unit of blood and blood components so that all steps can be clearly traced.
No Action Indicated (NAI)
Aug 6, 2009
Biologics · Human Cellular, Tissue, and Gene TherapiesBiologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Recalls
13 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
Erie, Pennsylvania, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.