1Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality ofthe drug product.
Inspection Record
Diabetes Corporation of America — FDA 483 Findings
Inspectors Zada L. Giles · Laura L. StaplesThe 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
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
3Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
7Aseptic processing and sterility assurance
Drug product containers and closures were not sterilized.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
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.
