When particulate matter is detected in sterile injectable products, manufacturers must take swift, structured steps...
FDA Injectable Drug Recall Notices: Interactive Chart
Manual visual inspection plays a crucial role in upholding product integrity, patient safety, and regulatory compliance. Let's dive into the details of this essential quality control measure.
Ensuring compliance with Section 501 of the FD&C Act is vital for maintaining the safety,...
Injectable products are a type of pharmaceutical formulation designed to be administered directly into the...
Injectable products are a type of pharmaceutical formulation designed to be administered directly into the body through a needle. This approach allows the medication to...
Properly designed defect test sets are essential for qualifying inspectors in pharmaceutical visual inspection. This post explores the optimal size, defect percentage, and customization needed...
A defect library is a crucial quality control tool that enhances defect identification, classification, and management in pharmaceutical manufacturing. By providing a standardized reference, it...
An effective CAPA process for visual inspection issues is crucial for maintaining product quality and regulatory compliance. By avoiding common pitfalls like inadequate data analysis,...
To ensure compliance with regulatory expectations and enhance the quality of injectable products, a robust visual inspection program must integrate supplier quality agreements, risk assessments,...
Injectable products contaminated with visible particulates, such as glass or rubber, can cause severe complications including inflammation, tissue damage or embolic events. The pharmaceutical industry...
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Manual visual inspection plays a crucial role in upholding product integrity, patient safety, and regulatory compliance. Let's dive into the details of this essential quality control measure.
A defect library is a crucial quality control tool that...
An effective CAPA process for visual inspection issues is crucial...
To ensure compliance with regulatory expectations and enhance the quality...
Injectable products contaminated with visible particulates, such as glass or...
Manual visual inspection is essential for detecting particles in injectable...
The affected batches were inadvertently released to the market prior...
FDA Injectable Drug Recall Notices: Interactive Chart
Ensuring compliance with Section 501 of the FD&C Act is vital for maintaining the safety, quality, and efficacy...
Injectable products are a type of pharmaceutical formulation designed to be administered directly into the body through a...
Properly designed defect test sets are essential for qualifying inspectors in pharmaceutical visual inspection. This post explores the...
FDA Injectable Drug Recall Notices: Interactive Chart
Ensuring compliance with Section 501 of the FD&C Act is vital for maintaining the safety, quality, and efficacy of pharmaceutical products. Strict adherence to environmental...
Injectable products are a type of pharmaceutical formulation designed to be administered directly into the body through a needle. This approach allows the medication to...
Properly designed defect test sets are essential for qualifying inspectors in pharmaceutical visual inspection. This post explores the optimal size, defect percentage, and customization needed...
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The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter which may result in leakage. To date, there have been no customer complaints received and there have been no reports of serious injury...
Par Pharmaceutical, Inc. has voluntarily recalled one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product was recalled due to the potential for the presence of silicone particulates in the product solution.
The recall was initiated due to the potential for presence of glass particulate matter, identified during product inspection.
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