1Other quality system
we identifie d that thi s exact lot was subject to an environmental excursion documented in the "Summar y an d Analysi s of Area <Redacted B4> Env iron ment and Gown ing Data for Ma y 201 7".
Inspection Record
Cantrell Drug Company — FDA 483 Findings
Inspectors Haijing HuThe 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 of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
3Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
7Quality unit oversight
The quality control unit lacks authority to fully investigate errors that have occurred.
8Stability and storage
There is no written teting program designed to assess the stability characteristics of drug products.
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.
