1Stability and storage
There is no written testing program designed to assess the stability characteristics of dm g products.
Inspection Record
Cantrell Drug Company — FDA 483 Findings
Inspectors Latorie S Jones · Lisa R JenningsThe 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
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency pmticulate air filters lmder positive pressure.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of dmg products pmporting to be sterile are not established, written and followed.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been aheady disu·ibuted.
6Aseptic processing and sterility assurance
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of dmg products.
7Equipment and facility
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix ups between different components, mug product containers, labeling, in-process materials and m11g products and to prevent contamination.
8Labeling and packaging
The labels of your outsourcing facility's dmg products are deficient.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
10Deviation, CAPA, and investigation
Deviations from written production and process control procedures are not recorded and justified.
11Aseptic processing and sterility assurance
Test procedures relative to appropriate laborat01y testing for sterility and pyrogens are not written and followed.
12Laboratory and QC controls
Testing and release of dmg product for distribution do not include appropriate laboratory detetmination of satisfactory conf01mance to the identity and strength of each active ingredient prior to release.
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.
