1Equipment and facility
The facility is designed and operated in a way that may permit the influx of lesser quality· air into a higher quality air area.
Inspection Record
Central Admixture Pharmacy Services, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
From 4/26/2022 to 4/28/2022, we observed employees use non-sterile <Redacted B4> to clean and sanitize materials entering into the ISO 5 Laminar Air Flow Bench areas.
3Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO S classified aseptic processing areas were not sterile.
4Aseptic processing and sterility assurance
Media tills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
5Aseptic processing and sterility assurance
The media fill ro ram is deficient in that operator qualification of their media fills are performed in batch sizes of <Redacted B4> and <Redacted B4> in a <Redacted B4> bag using the <Redacted B4> compounder, however, the smallest <Redacted B4> batch size that is produced by your firm is <Redacted B4> for neonates and the largest batch size for other patients is <Redacted B4>.
About this record
Extracted automatically from the document US FDA published on 2022-06-24. 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.
