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Form 483 Remediation

Posted by Aniket Chaudhari on November 29, 2023 at 4:50am 0 Comments

Medical device manufacturers receive observations (Form 483) and / or warning letters on completion of USFDA Audit. The document outlines any violations of Good Manufacturing Practices (GMP’s) such as the facility, equipment, processes, controls, products, employee practices or records.IZiel has successfully assisted medical device companies to resolve these observations with efficiency and accuracy.

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Potassium Silicate Prices: Trend, Pricing, Analysis | ChemAnalyst

Posted by Ganesh Kumar on November 29, 2023 at 4:49am 0 Comments

For the Quarter Ending September 2023

North America:



In the third quarter of 2023, the cost of Potassium Silicate witnessed a downward trajectory, as reported by the ChemAnalyst. The manufacturing sector in the United States encountered persistent challenges during this period, characterized by a notable decrease in new orders and subdued domestic demand from the construction industry. This challenging business environment prompted companies to scale back procurement activities,… Continue

USFDA Regulatory Consultants

Posted by Aniket Chaudhari on November 29, 2023 at 4:49am 0 Comments

IZiel helps you to obtain US FDA and CE approvals for Class I, II & III Medical Devices. Our Regulatory Consultants in US, Europe and India have thorough knowledge of USFDA & MDR Requirements alongwith extensive experience in submissions and approvals. IZiel works with the company to develop comprehensive documents in compliance with the regulatory requirements.

Read more@ https://iziel.com/usfda-approval/

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