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Contamination Control
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: Proper gowning ensures contamination prevention; smoke studies simulate contamination control in real scenarios. Excerpt: There is no gowning qualification program at your facility...your smoke study was not conducted under dynamic conditions. View Details |
| Contamination was observed in your production area and areas adjacent to production areas Avenue Pharmacy Inc dba Pathway Pharmacy |
04 Oct 2024 | Normal | Justification: Contamination Control is relevant because it directly pertains to preventing contamination in the manufacturing environment. Excerpt: Contamination was observed in your production area and areas adjacent to production areas. View Details |
| Your firm failed to perform adequate smoke studies under dynamic conditions Brookfield Medical Surgical Supply, Inc. |
27 Sep 2024 | Normal | Justification: Contamination Control is crucial as the observation reveals that inadequate smoke studies may lead to contamination risks. Excerpt: Inadequate quantity of generated smoke does not allow for an adequate determination that manipulations do not interfere. View Details |
| Your firm failed to follow procedures designed to prevent microbiological contamination of drug products Brookfield Medical Surgical Supply, Inc. |
27 Sep 2024 | Normal | Justification: This observation directly relates to contamination control as it addresses failure to prevent microbiological contamination. Excerpt: Your firm failed to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile. View Details |
| Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. RC Outsourcing, LLC |
27 Sep 2024 | Normal | Justification: Contamination control is compromised without proven efficacy of disinfectants, affecting aseptic conditions. Excerpt: No disinfectant efficacy testing has been conducted for the disinfectants used on supplies and work surfaces. View Details |
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