1Other quality system
There is a failure to throughly investigate batches that do not meet specification.
Inspection Record
Jacobus Pharmaceutical Company, Inc — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Facilities used in the manufacture and storage of components, active pharmaceutical ingredients, and in-process materials are inadequate .
3Other quality system
Containers used during the production of drug products are not identified at all times.
4Equipment and facility
Equipment used in the manufacture of drug products are not maintained in a state of repair.
5Laboratory and QC controls
The written stability program for drug products does not include specific, meaningful, and reliable test methods.
6Material and supplier control
Test results from component suppliers are accepted without testing each component according to the established specification without evaluating the reliability of the supplier's analyses.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
