1Quality unit oversight
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the quality and purity of drug products.
Inspection Record
Baxter Healthcare Corporation — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The quality control unit lacks the responsibility and authority to reject all drug products.
3Equipment and facility
Routine calibration and inspection of electronic equipment is not performed according to a written program designed to assure proper performance.
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.
5Process 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.
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.
