1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of sterile drug products does not include adequate validation of aseptic 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
2Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality, and purity.
3Deviation, CAPA, and investigation
There is a failure to thoroughly investigate any unexplained discrepancy or failure of a batch, regardless of whether the batch has been distributed, or a failure to expand an investigation to assess other batches that may also be impacted.
4Other quality system
Input to and output from the computer, related systems of formulas, records or data are not checked for accuracy.
5Laboratory and QC controls
Samples taken ofdrug products for determination of conformance to written specifications are not representative.
6Quality unit oversight
The quality control unit lacks the responsibility and authority to reject all drug products.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
9Aseptic processing and sterility assurance
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic 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.
