Webinar – Pharma Quality Inspection and Enforcement Trends in Japan

Tianish Laboratories Private Limited: A Timeline of Regulatory Assessments

Tianish Laboratories Private Limited (formerly known as Mylan Drugs India Pvt. Ltd) identified as a API (Active Pharmaceutical Ingredients) manufacturer. The FDA has inspected multiple sites associated with Tianish Laboratories Private Limited. This page documents the most recent 5 inspection documents associated with the HYDERABAD TELANGANA site, where the last known inspection was on 08 […]

KVK-Tech Warning Letters: A Timeline of Regulatory Assessments

FDA issued KVK-Tech, Inc (Newtown, PA) a Warning Letter on October 8, 2020, based on the outcome of an inspection ending March 13, 2020 (Link to the corresponding FDA 483). Additionally, the firm had also received a Warning Letter on February 11, 2020, based on the outcome of an inspection ending April 16, 2019 (Link […]

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Report – Analysis of FDA 483 issued to Cipla Limited

Report – Analysis of FDA 483 issued to Jiangsu Hengrui Pharmaceuticals

Report – Aurobindo’s Quality Problems: A Timeline of Regulatory Actions and Recalls

Webinar – CMO Inspection and Enforcement Trends 2020-2023
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