1Aseptic processing and sterility assurance
The firm does not maintain reserve samples for any sterile drug products manufactured and distributed.
Inspection Record
PharMEDium Services LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
The firm's procedures do not include requirements for analytical testing of incoming,commercially available drug products which are used in the production of sterile, finished drug products distributed to consignees.
3Aseptic processing and sterility assurance
The firm's disinfectant effectiveness studies do not included microbial challenge (microbial recovery) studies to demonstrate that REDACTED (b)(4) and REDACTED (b)(4) are effective sanitizing agents in the interior of the REDACTED (b)(4) Laminar Flow Hoods (Class 100) used in the production of sterile drug products.
4Aseptic processing and sterility assurance
The firm's procedure for sanitizing supplies and equipment used to manufacture lots of sterile drug products does not provide assurance that adequate sanitization with the secondary method of using REDACTED (b)(4) is performed.
5Stability and storage
The firm does not conduct on-going stability studies for any finished drug products which are manufactured and distributed to provide assurance that the established expiry dates of 15 days, 30 days, and 45 days remain valid.
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.
