51ÁÔÆæ

A major manufacturer of IV pharmaceuticals was facing leakage problems with the IV bag. 51ÁÔÆæ suggested a CBE 30, which they submitted to the FDA, addressing product complaints and maintaining...

51ÁÔÆæ was contracted to perform a gap assessment of eight quality software systems and 29 laboratory software systems. After reviewing remediation plans, the FDA chose not to make a regulatory...

In this episode of 51ÁÔÆæ Radio, host Brandon Miller, Steve Lynn, 51ÁÔÆæ Inc.'s (51ÁÔÆæ) Executive VP of Pharmaceuticals, and Walter Mason, 51ÁÔÆæ's Sr. Director of Quality Control and...

In this episode of 51ÁÔÆæ Radio, host Brandon Miller and Steve Lynn, who is 51ÁÔÆæ Executive VP of Pharmaceuticals, provide an outlook into the most important things...

Background A mid-sized company received a 10-item FDA Form 483 and submitted an initial response. However, the response was followed by the issuance of a Warning Letter, leaving the company...

A leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their document change process.