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FDA establishment 3019769008, Lauderhill, Florida, United States. Part of Hemarus LLC's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 1
Last inspection ended: Apr 30, 2024
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 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, storage and distribution of blood and blood components for 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 processing of each unit of blood and blood components so that all steps can be clearly traced.
21 CFR 630.5(c)(1). Improper delegation of activities - SP & plasmapheresis The responsible physician improperly delegated donor eligibility activities related to the collection of Source Plasma.
21 CFR 630.5(b)(2). Responsible physician not on site The responsible physician was not present at the collection site when activities related to the collection of blood and blood components were delegated to a trained person who was not adequately trained and experienced in the performance of the activities.
21 CFR 606.160(d). Retention period Failure to retain records for 10 years after the records of processing have been completed.
21 CFR 606.171. Biological product deviation report Failure to submit a biological product deviation report.
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)(2). Name, address, unique facility identifier The container label fails to include the license number of each manufacturer, for a licensed product.
21 CFR 606.20(b). Qualifications of responsible personnel The personnel responsible for the collection, processing, 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 606.40(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 606.170(a). Adverse Reaction - Investigations A thorough investigation of each reported adverse reaction was not made.
Official Action Indicated (OAI)
Nov 4, 2022
Biologics · Vaccines and Allergenic ProductsBiologics · Blood and Blood Products
2 cited references
21 CFR 606.40(a)(1). Provide space for examination Failure to provide adequate space for examinations of individuals to determine their eligibility as blood donors.
21 CFR 606.170(a). Adverse Reaction - Investigations A thorough investigation of each reported adverse reaction was not made.
No Action Indicated (NAI)
Warning Letters
Letters naming this establishment; each opens the letter
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. 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 and warning letters
Lauderhill, Florida, United States. Part of