1Stability and storage
The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.
Inspection Record
Symbiosis Pharmaceutical Services Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The retention period for drug product reserve samples (except those described in 211.170(b)(2) and (3)) is deficient in that they are not retained for one year after the expiration date of the drug product.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
4Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
6Equipment and facility
Buildings used in the manufacturing of a drug product are not maintained in a good state of repair.
About this record
Extracted automatically from the document US FDA published on 2026-07-21. 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.
