1Material and supplier control
Each lot ofa component that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.
Inspection Record
Jubilant HollisterStier General Partnership — FDA 483 Findings
Inspectors Crystal MonroyThe 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
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written.
3Other quality system
The statistical qualit)· control criteria fail to include appropriate acceptance levels and rejection levels.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
5Aseptic processing and sterility assurance
Procedures desi~ned to prevent microbioloeical contamination of drug proilnl:'.t~ purporting to be sterile did not include adequate validation ofthe aseptic process.
6Aseptic processing and sterility assurance
Written procedures for cleaning and maintenance fail to include parameter relevant to the operation Specifically, Your firm does not use sterile disinfectants to clean the aseptic processing and filling areas.
7Laboratory and QC controls
Each batcb ofdrug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
9Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
10Complaint and recall handling
Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of any complaint involving the possible failure ofa dnig product to meet any of its specificationis and a d~bmuiuation as to the need for an investigation of any unexplained discrepancy.
11Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures design to assure that in process materials conform to appropriate standards of quality and purity.
12Laboratory and QC controls
Each batch of product required to be free ofobjectionable microorganisms is not tested through appropriate laboratory testing.
About this record
Extracted automatically from the document US FDA published on 2025-07-31. 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.
