1Quality unit oversight
The quality control unit lacks responsibi lity to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
Inspection Record
QuVa Pharma, Inc — FDA 483 Findings
Inspectors Guerlain UlysseThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic 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.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Material and supplier control
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
5Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that conform to appropriate standards of identity, strength, quality and purity.
6Complaint and recall handling
Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up.
About this record
Extracted automatically from the document US FDA published on 2019-07-25. 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.
