28 02, 2011

What’s the big deal with Form FDA 483s?

By | 2017-05-29T10:35:28+00:00 February 28th, 2011|cGMP Quality Assurance and FDA 483s, FDA, FDA Inspections, Form FDA 483|

by Tony Chen Okay, let’s settle this once and for all.  This week, we will be writing a series of posts that will give you an industry primer for what these Form FDA 483s are, why they’re important, how to avoid them, and how to respond to them.  Today, we cover the basics.  Some of you pros out there know [...]

24 02, 2011

10 Reasons Why the Deviation Investigation System Fails

By | 2016-07-08T14:18:34+00:00 February 24th, 2011|CGMP, cGMP Quality Assurance and FDA 483s, FDA, quality assurance|

For some companies, manufacturing is a crapshoot. There is little basis for confidence that that the right equipment, materials, components, people and records will be at the right place and the right time to begin manufacturing. And once manufacturing starts, a crystal ball is as good as anything to divine whether the product batch will be released on schedule. [...]