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Distribution
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| The process (equipment and procedures) for the storage and shipment of commercial drug product (DP) has not been validated Lonza Netherlands B.V. |
12 Jul 2024 | Normal | Justification: Distribution processes are affected as they require validated methods for shipping drug products. Excerpt: The proposed commercial DP shipping validation study has not been performed. View Details |
| Control procedures are not established which validate the performance of distribution processes Sichuan Deebio Pharmaceutical Co. Ltd. |
08 Sep 2023 | Normal | Justification: Distribution is fundamentally linked to this observation as it involves the processes ensuring that the drug substance remains within specified conditions during shipping. Excerpt: your firm ships USP drug substance with temperature storage specifications of (1) (b) (b) to (4) degrees Celsius for temperature, and (b) (4) % RH. There is no official validation study regarding the shipping container and components used which provide assurance that the (b) (4) USP drug substance in transit stays within its specified range for the duration of the shipment. View Details |
| Your firm's quality unit's oversight of your GMP manufacturing operations is inadequate. Hugel, Inc. (Site 2) |
10 Mar 2023 | Normal | Justification: Unvalidated shipping conditions may affect sample integrity. Excerpt: Shipping validations for samples tested in your contractor testing laboratories have not been conducted. View Details |
| Distribution records do not contain the lot or control number of drug product Family Dollar Distribution Inc. |
11 Feb 2022 | Normal | Justification: The failure to record lot numbers directly impacts the Distribution process, as it is essential for tracking and tracing drug products throughout the supply chain. Excerpt: Specifically, your firm does not document in your inventory control system the lot numbers of drug products received by your facility. In addition, your firm does not document the lot numbers of drug products that are shipped/distributed from your facility to your stores. View Details |
| Drug products are not stored under appropriate conditions of temperature and humidity SO that their identity, strength, quality, and purity are not affected. Family Dollar Distribution Inc. |
11 Feb 2022 | Normal | Justification: The observation indicates a failure to maintain controlled environmental conditions in the warehouse, crucial for preserving drug product quality during storage. Excerpt: Specifically, your firm does not monitor nor control temperature or humidity within your warehouse... View Details |
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