1Other quality system
Employees engaged in the manufacture, processing.
Inspection Record
PharMEDium Services, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The control systems necessary to prevent contamination or mix-ups are deficient.
3Labeling and packaging
The labels and containers of your outsourcing facility's drug products do not include information required by section 503B(a)(1O)(A) and (B).
4Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
5Training and personnel
Clothing of personnel engaged in the 'manufacturing, processing, packing, and holding of drug products is not appropriate for the duties they perfonn.
6Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
8Equipment and facility
The flow of components, drug product containers, closures, in-process materials, and drug products though the building is nOt designed to prevent contamination.
9Documentation and records
The batch production and control records are deficient in that they do not include specimen and copy of labeling.
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.
