1Cleaning validation
There is a lack ofadequate controls in place to minimize the carryover ofthe residual materials into successive batches of the same intermediate or API.
Inspection Record
Ipca Laboratories Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Buildings and facilities used to manufacture APis are not maintained appropriately to facilitate cleaning and to minimize potential contamination.
3Laboratory and QC controls
The suitability of analytical test methods is deficient for its intended use.
About this record
Extracted automatically from the document US FDA published on 2026-02-05. 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.
