1Laboratory and QC controls
The accuracy, specificity and reproducibility of test methods have not been established and documented.
Inspection Record
DynaLabs LLC — FDA 483 Findings
Inspectors Emilie Kahn · Nicole A Lloyd · Michael G TruchanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The written stability program for drug products does not include reliable, meaningful and specific test methods.
3Deviation, CAPA, and investigation
three other occurrences of this deviation type were reported (D19-193, Dl9-368, and Dl9-229).
4Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
5Deviation, CAPA, and investigation
Deviations from written specifications, standards, test procedures and laboratory mechanisms are not recorded and justified.
About this record
Extracted automatically from the document US FDA published on 2020-02-24. 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.
