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Material Storage and Control
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Written procedures are lacking which describe in sufficient detail the storage of components, drug product containers and closures Annovex Pharma, Inc. |
06 Sep 2024 | Normal | Justification: Storage requirements are critical for material integrity. The observation indicates lapses in precisely documented procedures which are vital for 'Material Storage and Control'. Excerpt: Written procedures are lacking which describe in sufficient detail the storage of components, drug product containers and closures. View Details |
| There was a failure to handle and store drug product containers at all times in a manner to prevent contamination Alkem Laboratories Limited |
27 Mar 2024 | Normal | Justification: The observation directly points to systemic failures in storing APIs in accordance with necessary guidelines to prevent contamination, making 'Material Storage and Control' the fundamental process type affected. Excerpt: Trying to mix APIs without a risk assessment and failing to adhere to manufacturer recommended storage conditions. View Details |
| There was a failure to handle and store components at all times in a manner to prevent contamination Nanchang Anobri Pharmaceutical CO., LTD |
21 Nov 2023 | Normal | Justification: The issue is directly related to storage and control of materials which failed due to leakage and oversight. Excerpt: leakage at the interface of the valve...no work order has been generated for addressing the leakage. View Details |
| Your firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality. Shilpa Medicare Limited |
09 Nov 2023 | Normal | Justification: Issues in the storage and control of raw materials pending testing results directly impact 'Material Storage and Control' process type. Excerpt: For example, (b) (4) (material code (b) (4) ) was not tested for (b) and (b) (4) contaminations before (A) use... View Details |
| Drug products are not stored under appropriate conditions of humidity Eisai Company Ltd. |
27 Oct 2023 | Normal | Justification: Proper material storage conditions are critical for maintaining the integrity of drug products. Uncontrolled humidity can lead to degradation, impacting identity, strength, quality, and purity. Excerpt: Your firm stores capsules in Warehouse 2, where humidity is not controlled and there are no predefined specification limits for the humidity. View Details |
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