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Process Monitoring
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Nephron Sterile Compounding Center LLC |
25 Sep 2024 | Normal | Justification: Process Monitoring requires accurate reflection of operational conditions to ensure controlled environments. Excerpt: Monitoring is performed at the (b) (4) of the batch and then at the (b) (4) of the operational shift. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established Empower Pharmacy |
28 Aug 2024 | Normal | Justification: Process Monitoring is critical here as the failure to properly monitor non-viable particles led to deviations impacting product sterility assurance. Excerpt: A full batch was released despite a reported deviation in non-viable particle monitoring in the ISO 5 areas. View Details |
| Ventilation systems, including equipment for control of air pressure, are not adequately designed and constructed to minimize risks of contamination. Taenaka Kogyo Co., Ltd. |
12 Apr 2024 | Normal | Justification: Active monitoring of critical process parameters is essential to ensure compliance and prevent contamination. Excerpt: No personnel are assigned to monitor the gauge while manufacturing operations are taking place inside the suite. View Details |
| Equipment used in the manufacture, processing, packing or holding of drug products is not suitably located to facilitate operations for its intended use. Eugia SEZ Private Limited |
29 Feb 2024 | Normal | Justification: Effective process monitoring is compromised due to the NVPC's incorrect location, which is essential in maintaining environmental monitoring during critical operational steps. Excerpt: There is no NVPC data to represent conditions during (b) (4) interventions that require movement of (b) (4) conveyor, or of any interventions (b) (4) (b) (4) performed through RABS No. View Details |
| Batch production and control records do not include complete information relating to the production and control of each batch Eugia Pharma Specialities Limited |
02 Feb 2024 | Normal | Justification: Interventions were not recorded accurately, leading to potential non-conformance. Excerpt: Review of the intervention records showed production personnel did not document all interventions or document interventions accurately. View Details |
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