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Equipment Cleaning
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | 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: Equipment Cleaning is critical as the observation highlights dirty and damaged equipment surfaces that could cause contamination. Excerpt: I observed (b) (4) AC units...contain white powder residue and dust which could potentially lead to product contamination. View Details |
| Your firm failed to follow written procedures for the cleaning and maintenance of equipment Brookfield Medical Surgical Supply, Inc. |
27 Sep 2024 | Normal | Justification: Equipment Cleaning is directly linked as the observation concerns failures in following cleaning procedures. Excerpt: Your firm failed to follow written procedures... View Details |
| Equipment and utensils are not cleaned at appropriate intervals Granules India Limited |
06 Sep 2024 | Normal | Justification: The observation states that equipment was not cleaned appropriately since installation, indicating a failure in the equipment cleaning process. Excerpt: A. The (b) (4) (b) (4) non-dedicated used in the manufacturing of drug products at your firm have not been appropriately cleaned since their installation several years ago. View Details |
| Equipment and utensils are not cleaned at appropriate intervals to prevent... Granules India Limited |
06 Sep 2024 | Normal | Justification: The observation directly mentions the failure to clean equipment, linking it to the 'Equipment Cleaning' process type. Excerpt: The non-dedicated equipment used in the manufacturing of drug products at your firm have not been appropriately cleaned since their installation several years ago. View Details |
| Equipment and utensils are not cleaned at appropriate intervals Granules India Limited |
06 Sep 2024 | Normal | Justification: Cleaning of non-dedicated equipment is crucial to prevent cross-contamination and maintain drug product quality. Excerpt: The (b) (4) (b) (4) non-dedicated used in the manufacturing of drug products at your firm have not been appropriately cleaned since their installation several years ago. View Details |
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