1Other quality system
A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not established, maintained, defined and documented.
Inspection Record
Liveyon Labs Inc — FDA 483 Findings
Inspectors Abby L Mozeke-Baker · Tania Y HallThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
3Contamination control
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and folJowed.
4Other quality system
Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the aseptic process.
6Stability and storage
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
7Other quality system
HCT/P donors were not determined to be eligible based on the results of donor screening and testing.
8Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
9Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
About this record
Extracted automatically from the document US FDA published on 2020-02-03. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
