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Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | 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: The HVAC system's adequacy directly impacts the ability to maintain critical pressure differentials to prevent contamination. Excerpt: The heating, ventilation, and air conditioning (HVAC) system used to establish the specified differential pressure between the production suites and the neighboring outside environment are not sufficient. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. Eugia Pharma Specialities Limited |
02 Feb 2024 | Normal | Justification: The observation indicated deficiencies in HVAC system validation, especially concerning air quality and particle control in aseptic environments. Excerpt: Qualification of the HVAC system...did not demonstrate it can maintain appropriate air quality for aseptic filling...smoke studies have not evaluated if air flow...would allow air ingress... View Details |
| Your firm failed to establish adequate written procedures for production and process controls Charles River Laboratories, Inc. |
04 Jan 2024 | Normal | Justification: The HVAC system's influence on cleanroom conditions directly impacts the maintenance of appropriate environmental standards necessary for drug production. Excerpt: The cleanroom airflow and differential pressure was determined to be affected by HVAC system settings...a loose HEPA filter acoustic liner. View Details |
| There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed Charles River Laboratories, Inc. |
04 Jan 2024 | Normal | Justification: The observation explicitly mentions HVAC settings impacting cleanroom compliance, making this process type relevant. Excerpt: The cleanroom airflow and differential pressure was determined to be affected by HVAC system settings. View Details |
| Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. Charles River Laboratories, Inc. |
04 Jan 2024 | Normal | Justification: Issues with cleanroom settings directly linked to HVAC system settings suggest a critical deficiency in HVAC management and integration. Excerpt: The cleanroom airflow and differential pressure was determined to be affected by HVAC system settings... View Details |
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