1Labeling and packaging
(bsc 9/22/14) I < I I i The labels of your outsourcing facility’s drug products do not include the information required by s ection 503B (a)(10)(A)&(B).
Inspection Record
Triangle Compounding — FDA 483 Findings
Inspectors Investigator Tomika L. Bivens · Bonita S CijesterThe 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
i i Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
3Material and supplier control
There is a lack of written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, exa mination, and testing of labeling and packaging materials.
4Material and supplier control
I Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all ap propriate written specifications, without establishing the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy 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.
