1Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Dmg, and Cosmetic Act (FD&C Act).
Inspection Record
Annovex Pharma, Inc — FDA 483 Findings
Inspectors Tekalign WondimuThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been aheady distributed.
3Other quality system
Records associated with drug product production and control and within the retention period for such records, were not made readily available for authorized inspection.
4Regulatory reporting and change control
Your outsourcing facility did not submit a repo1t to FDA identifying the di11gs compounded during the previous six month period.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Aseptic 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.
7Material and supplier control
Written procedures are lacking which describe in sufficient detail the storage of components, diug product containers and closures.
About this record
Extracted automatically from the document US FDA published on 2024-10-02. 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.
