JVT

Analysis and Case Study Review: FDA Warning Letter To Tismor Health and Wellness

On 5 December 2019, the US FDA issued a Warning Letter (320-20-10) to the Australian firm Tismor Health and Wellness Pty Limited, following an inspection conducted on May 20 to 24, 2019.  The source of this Warning Letter is: Warning Letter to Tismor Health and Wellness Pty., dated December 5, 2019 OBSERVATION This US FDA observation is related to 21 CFR Part 211.68(b). This section in the CGMP manufacturing of drug and finished pharmaceuticals is associated with the automatic systems performing CGMP functions. 211.68(b) regulation, related to e-records integrity, provides the following principles:   Access...

This content is only available to IVT members.
Get help maintaining your knowledge . Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Product Added Successfully

This product has been added to your account and you can access it from your dashboard. As a member, you are entitled to a total of 0 products.

Do you want access to more of our products? Upgrade your membership now!

Your Product count is over the limit

Do you want access to more of our products? Upgrade your membership now!

Product added to cart successfully.

You can continue shopping or proceed to checkout.