1Contamination control
The control systems necessary to prevent contamination or mix-ups are deficient.
Inspection Record
Triangle Compounding, Cary, NC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would .
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
4Process validation
There are no written procedures for production arid process controls designed to assure that the drug products have the , i identity, strength, quality, and purity they purport or are represented to possess.
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.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
