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Preventive Maintenance
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | 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: Preventive Maintenance is implicated as proper maintenance is crucial to ensuring equipment cleanliness and functionality. Excerpt: Your firm failed to follow...maintenance of equipment... View Details |
Apitoria Pharma Private Limited |
27 Sep 2024 | Normal | Justification: Preventive maintenance is linked as the issue stems from a failure in maintaining equipment conditions per required standards. Excerpt: maintenance check lists don't record the checking for scratch marks and dents. View Details |
| Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance. ProRx LLC |
02 Aug 2024 | Normal | Justification: The HVAC system's role in maintaining cleanroom conditions is critical, and its maintenance is essential. Excerpt: HVAC, used to supply the cleanroom with adequate temperature and humidity... View Details |
| Facility and equipment are not maintained in a manner that prevents contamination of APIs by other materials. Global Calcium Pvt. Limited |
02 Aug 2024 | Normal | Justification: Effective preventive maintenance could have mitigated the infrastructure issues leading to potential contamination. Excerpt: (b) (4) liquid was observed surrounding the (b) (4) On July 30, 2024, unidentified pipe which transfers (b) (4) View Details |
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Gland Pharma Limited, Units I+II |
02 Aug 2024 | Normal | Justification: A preventive maintenance program ensures reliable operation of equipment, preventing failures. Excerpt: The firm has not established appropriate preventive maintenance program based on historical maintenance data. View Details |
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