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FDA establishment 3012029940, Huntingdon Valley, Pennsylvania, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 3
Official action indicated: 0
Last inspection ended: Feb 10, 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 606.121(c)(12). Labeling; test results for rel transmitted infections The container label of blood and blood components failed to list the results of tests demonstrating evidence of infection due to relevant transfusion-transmitted infections as required under the regulations.
21 CFR 630.10(e). Medical History Interview Failure to conduct a medical history interview prior to collection of blood or blood components to identify risk factors closely associated with exposure to, or clinical evidence of, a relevant transfusion-transmitted infection.
21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the collection, storage and distribution 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, storage and distribution of blood and blood components for further manufacturing purposes were not always established, maintained and followed.
21 CFR 610.40(a)(2). Test for HTLV, syphilis, West Nile, Chagas Failure to test each donation of blood and blood components intended for transfusion or for use in manufacturing a product for evidence of infection with HTLV and Chagas disease.
21 CFR 630.15(b)(1). Medical history and physical exam Failure of the responsible physician to conduct an appropriate medical history and physical examination of the donor on the day of the first donation or no more than 1 week before the first donation and at subsequent intervals of no longer than 1 year and conduct a new medical history and physical examination of a donor who does not return for 6 months.
21 CFR 630.5(d). CPR certification Failure to assure that an individual who is currently certified in cardiopulmonary resuscitation is located on the premises whenever collections of blood or blood components are performed.
21 CFR 610.40(a). Test for HIV, HBV, HCV Failure to test each donation of blood and blood components intended for transfusion or for use in manufacturing a product for evidence of infection with HBV.
21 CFR 606.60(a). Equipment observed, standardized, calibrated Equipment used in the collection and storage and distribution of blood and blood components is not standardized and calibrated on a regularly scheduled basis as prescribed in the SOP Manual.
Voluntary Action Indicated (VAI)
Jul 31, 2019
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Mar 14, 2018
Biologics · Blood and Blood Products
9 cited references
21 CFR 606.160(a)(2). Determination of lot numbers and supplies Appropriate records are not available to determine the lot numbers of supplies used for specific units of the final product.
21 CFR 606.121(c)(11). Required labeling information - manufacturing use For products intended for further manufacturing use, the container label failed to contain a statement listing the results of all tests for relevant transfusion-transmitted infections required under the regulations found to be negative.
21 CFR 606.121(c)(4)(i). Expiration date The container label fails to include the expiration date, including the day, month, and year.
21 CFR 606.110(b). Center approval for collection of rare antibodies The plasmapheresis of donor(s) whose blood contained rare antibodies but did not meet the donor requirements for donor eligibility was performed without the prior approval of the Director, Center for Biologics Evaluation and Research.
21 CFR 606.121(c)(1). Proper name of product The container label fails to include the proper name of the product in a prominent position.
21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the collection, processing and distribution of each unit of blood and blood components so that all steps can be clearly traced.
21 CFR 610.40(h)(2)(ii). Labeling of reactive units, units from deferred donors Human blood or blood components which had a reactive screening test for a relevant transfusion-transmitted infection were shipped, but the product labeling did not include the appropriate elements.
21 CFR 606.60(b). Equipment calibration frequency Equipment used in the collection and compatibility testing of blood and blood components is not observed, standardized and calibrated with at least the frequency required.
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 further manufacturing purposes were not always established.
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Huntingdon Valley, Pennsylvania, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.