1Other quality system
Your internal audit is not effective to verify compliance with the principles ofCGMP for APis.
Inspection Record
Aarti Drugs Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Written procedures is not established and followed for investigating critical deviations or the failure ofa batch of intermediate or API to meet specifications.
3Quality unit oversight
Responsibilities and procedures for quality units are not in writing and/or followed to ensure the API and intermediates manufactured at your facility are in compliance with CGMP.
4Laboratory and QC controls
Test procedures is not scientifically sound and appropriate to ensure that raw materials, intermediates, and APis, conform to established standards of quality and/or purity.
5Laboratory and QC controls
You assign the storage conditions and retest or expiry dates ofthe APis using test procedures that are not stability indicating.
6Other quality system
Records associated with the API distribution were not readily available for inspection.
7Equipment and facility
Written procedures are not established for cleaning ofequipment and its subsequent release for use in the manufacture of intermediates and APis.
About this record
Extracted automatically from the document US FDA published on 2024-11-01. 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.
