1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not fully established and/or followed.
Inspection Record
Central Admixture Pharmacy Services, Inc., (CAPS) — FDA 483 Findings
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 the system for monitoring environmental conditions.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
4Laboratory and QC controls
Laboratory controls do not include the establishment ofscientifically sound and appropriate sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
5Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
6Documentation and records
Batch production and control records do not include the specific identification of each batch of component or in-process material used for each batch of drug product produced.
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.
