Resources

This article covers how life sciences companies can use data intelligence to navigate regulatory compliance and avoid significant fines. It highlights advice from Jon Falker of Redica Systems, who emphasized establishing strong compliance practices early, including selecting trustworthy partners and analyzing inspection trends. The piece also addressed challenges in global supply chains and the […]

PLEASANTON, CA, December 18, 2024 — Redica Systems, a data analytics platform helping life sciences companies reduce compliance risk, today announced the successful completion of its Type 2 SOC 2 audit as of September 30, 2024, for the period of May 1, 2024, to August 31, 2024, as part of its security compliance. The SOC […]

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 […]