1Training and personnel
Employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions.
Inspection Record
Sentiss Pharma Pvt. Ltd. — FDA 483 Findings
Inspectors Sandra A Hughes · Eileen A LiuThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
Changes to written procedures are not reviewed and approved by the quality control unit.
3Laboratory and QC controls
The written stability program for drug products does not include reliable, meaningful and specific test methods.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Deviation, CAPA, and investigation
Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
7Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials and drug products conform to appropriate sta...
8Quality unit oversight
The quality control unit lacks the responsibility and authority to approve and reject all components.
9Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
About this record
Extracted automatically from the document US FDA published on 2026-08-05. 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.
