1Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination ofs atisfactory conformance to the final specifications prior to release.
Inspection Record
Liveyon — FDA 483 Findings
Inspectors Tania Y Hall · Investigator Thanh B TranThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
Storage temperatures of HCT/Ps were not recorded and maintained.
3Other quality system
Adverse reactions which involved a communicable disease related to an HCT/P made available for distribution and were fatal or life threatening, resulted in permanent impairment or damage to the body, or necessitated medical or surgical intervention, were not reported to FDA.
4Other quality system
The summary of records for HCT/Ps did not contain an interpretation of results of all communicable disease tests performed.
5Other quality system
Release criteria were not verified to have been met through a review of manufacturing and tracking records before HCT/Ps were made available for distribution.
6Complaint and recall handling
Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
7Equipment and facility
Equipment was not routinely inspected for calibration.
8Other quality system
Appropriate shipping conditions were not defined for each type of HCTIP.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
