4 03, 2016

7 Resources for Avoiding Form FDA 483s

By | 2017-11-06T03:57:33+00:00 March 4th, 2016|cGMP Quality Assurance and FDA 483s, FDA Inspections, Form FDA 483|

As we’ve written extensively about the infamous Form FDA 483 here at FDAzilla, we’ve decided to make it easier for you.  Here, we’ve created a centralized list of the 7 best resources to go from Joe to Pro on understanding Form FDA 483s. […]

1 03, 2011

Who can see Form FDA 483s, and where do I get them?

By | 2018-02-08T15:48:05+00:00 March 1st, 2011|cGMP Quality Assurance and FDA 483s, FDA, FDA Inspections, Food, Form FDA 483|

Previously, we talked a bit about what the big deal is about these Form FDA 483s.  Today, we talk about how to get a hold of actual 483 reports and who else can see them. This is where things get a little more tricky.  Theoretically, Form FDA 483s are public information and, thus, available through the FDA’s Freedom of Information [...]

1 02, 2011

Top 31 Websites (and Tweeters) on the FDA

By | 2017-11-06T01:20:01+00:00 February 1st, 2011|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDAzilla, Medical Devices|

If any part of your life includes trying to figure out how to work smarter with the FDA, this is for you.  Here’s our list of the top 40 31 online destinations on the FDA and some of the key industries it regulates.   We applied only one criteria to make it on this list:  free, up-to-date, and valuable content. […]

18 01, 2011

Tales from the Front: With the FDA in Costa Rica

By | 2017-11-06T03:55:34+00:00 January 18th, 2011|cGMP Quality Assurance and FDA 483s, FDA, FDA Inspection Stories, FDA Inspections, Form FDA 483|

The FDA had sent one of their best and toughest inspectors. The facility was located in Costa Rica.  I had been sent there from the US to help a sister company with a pending inspection. I had arranged a dinner the night before the start of the inspection at a (supposedly) nearby restaurant in order for the FDA inspector and [...]

17 01, 2011

State of the FDA

By | 2016-07-12T16:18:18+00:00 January 17th, 2011|FDA|

FDA’s touches the lives of every American at least 6 to 10 times each day. The agency oversees 80% of the nation’s food supply, all of animal/human medical cosmetics and products, and almost all radiation-emitting devices.  Put all that together, the agency is responsible for about 20% of all consumer dollars spent in the United States. With the President set [...]

11 01, 2011

Grand Rounds 1.11.11 | It’s Complicated

By | 2016-07-12T16:06:06+00:00 January 11th, 2011|cGMP Quality Assurance and FDA 483s, FDA Inspection Stories, FDAzilla|

When when I read the posts from this week’s grand rounds, I am astounded at how advanced, how intense, how personal, how vast, and also how amazingly complicated health care here in America is.  It’s so complicated that probably only the most astute health care observers and healthcare management degree students will even understand every post below. As you read [...]

4 01, 2011

FDA Inspections: Being prepared when you know you have problems

By | 2017-11-06T01:20:01+00:00 January 4th, 2011|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Inspections, Form FDA 483|

I am often asked how best to prepare for an FDA inspection when you already know that you have problems. My first response is that they have already taken the first step: acknowledging that there are problems. Believe me. That is a huge first step. Just like AA’s 12 step program, it’s not until you are willing to admit this [...]

28 12, 2010

Dec 2010 FDA Round-up: 5 Trending Topics

By | 2016-07-12T16:15:20+00:00 December 28th, 2010|cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement News|

We live in a news-driven world, and sometimes it’s like drinking out of a firehose.  So, to save time, here were some of the key developments related to the FDA over the last month. FDA vs. no FDA. Commissioner Hamburg wrote an elaborate piece on Innovation, Regulation, and the FDA, essentially justifying the existence of the FDA.  Well-written and rich [...]