1Aseptic 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.
Inspection Record
Turbare Manufacturing — FDA 483 Findings
Inspectors Logan T WilliamsThe 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written.
3Laboratory and QC controls
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness and compliance with established standards.
4Process validation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
5Process validation
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
6Quality unit oversight
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet appropriate statistical quality control criteria as a condition for their approval and release.
7Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been aheady distributed.
8Training and personnel
Employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions.
About this record
Extracted automatically from the document US FDA published on 2025-02-07. 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.
