1Other quality system
Products that do not conform to specifications are not adequately controlled.
Inspection Record
Baxter Healthcare Corporation — FDA 483 Findings
Inspectors Marvin D. JonesThe 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
TYPE ESTABLISHMENT INSPECTED Drug Manufacturer Records are not kept for the maintenance and inspection of equipment.
3Process validation
Control procedures ,are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
4Quality unit oversight
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release.
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.
