1Other quality system
Laborato1y records ai·e deficient in that they do not include a statement of the results of tests and how they compare to the established specifications.
Inspection Record
Jubilant HollisterStier General Partnership — FDA 483 Findings
Inspectors Rafeeq A Habeeb · Logan T WilliamsThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Laborato1y records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy.
3Laboratory and QC controls
The statistical quality control criteria fail to include appropriate acceptance levels and rejection levels.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products pmpo1iing to be sterile did not include adequate validation of the aseptic process.
About this record
Extracted automatically from the document US FDA published on 2024-10-29. 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.
