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Media Fill
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. OSRX Inc. |
25 Oct 2024 | Normal | Justification: Media fill process inadequacies are directly linked to improper aseptic operator qualification. Excerpt: Your firm's personal media fill is deficient in that aseptic operators only aseptically fill containers units. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation Annovex Pharma, Inc. |
06 Sep 2024 | Normal | Justification: Incorrect media fill practices directly impact the validation of aseptic processing, critical for maintaining sterility. Excerpt: Media fill program is inadequate as it does not provide an assurance that your staff can manufacture drug product under aseptic conditions. View Details |
| Records associated with drug product production and control were not made readily available Annovex Pharma, Inc. |
06 Sep 2024 | Normal | Justification: Media Fill records directly pertain to validations necessary for aseptic processing controls. Excerpt: Media Fill records from 06/27/2023, 6/28/2023 and 7/10/2023 were unavailable. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process ProRx LLC |
02 Aug 2024 | Normal | Justification: Media Fill directly impacts the assurance of sterile conditions during drug product manufacturing processes. Excerpt: Media fills are not performed in accordance with a written procedure, ProSOP-B052, SOP For Media Fill. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. Gland Pharma Limited, Units I+II |
02 Aug 2024 | Normal | Justification: Media Fill procedures are specifically mentioned as deficient due to lack of intervention tracking. Excerpt: The Aseptic Processing Simulation (APS, Media Fill) procedure SOP QA-0020-009, effective 31 May 2024, titled Procedure for Aseptic Process Simulation (Media Fill) is deficient in that it does not require tracking and trending of all types and time duration of interventions. View Details |
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