1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purpo rting to be sterile did not include adequate validation of the aseptic process.
Inspection Record
Somerset Therapeutics Private Limited — FDA 483 Findings
Inspectors Eileen A. Liu · Joseph A. PiechockiThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
3Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examination and assay necessary to assure compliance with established specifications and standards.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
5Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
8Complaint and recall handling
There is a failure to submit a field alert report (FAR) to FDA within 3 working days of receiving information concerning bacteriological contamination in the distributed drug product.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
About this record
Extracted automatically from the document US FDA published on 2026-05-06. 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.
