Resources

This article covers Glenmark Pharmaceuticals, an Indian drug manufacturer, which has issued seven recalls within a year for medications that failed to dissolve properly, a defect that can lead to serious health risks, including death. The following is a snip from the article: “To determine that the recalled Glenmark drugs were all made at […]

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 […]

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 […]