Inspect your FDA Inspector Before Your Inspection | FDAZILLA BLOG

Read the full article: Inspect your FDA Inspector Before Your Inspection | FDAZILLA BLOG:

"Each investigator brings their unique perspective, experience and idiosyncrasies, the study of which is demonstrated to be a crucial element of inspection management, readiness, and preparation. With the Inspector Profile, you’ll be able to see the inspector’s:

•  483 issue rate 
• Total inspections 
• Total 483s 
• Most common citations (based on CFR), CFR description, and citation frequency 
• Longest / shortest inspection in duration – all time, last year 
• Total warning letters"

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6 Questions For A Veteran FDA Investigator | FDAzilla Blog

6 Questions For A Veteran FDA Investigator | FDAzilla Blog:

"Today we have the privilege of interviewing former FDA investigator, Luis Chavarria. After 30 years of conducting, managing, and supervising inspections, his insights are worthy of heavy consideration."

You might also be interested in this course:
Surviving an FDA Inspection

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Fewer FDA Inspectors - More Device Complaints

Here's an excellent graphic crafted by Dan Nguyen and Christina Jewett, Graphic: At FDA, Fewer Inspectors Trace More Device Complaints. It's easy to understand that from 1997 through 2007, two major trends have emerged: 1) adverse event reports have risen dramatically over the years, and 2) the number of FDA FTEs in the medical device field division have steadily declined. What you have to do, to shock some reality into yourself, is to view their graphic. Go see it. 

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Think Like An FDA Inspector - Be Prepared

• FDA cGMP QSR GMP Training - respected online training courses by SkillsPlus Intl Inc.

Revised December 16, 2020

Yep, it's important to follow all the regulations. AND, it helps to understand how the FDA inspector will approach your company during an inspection. On the FDA website, several free documents are published as reference material for investigators and other FDA personnel. The documents don't bind the FDA and don't confer any rights, privileges, benefits or immunities for or on any person(s). Basically, they'll help you prepare and anticipate what to expect from an FDA inspector and inspection team. Just be forewarned, it also means that they don't have to follow the suggestions or recommendations mentioned in the inspection guides. Here's a listing of the major categories of inspection guides that are available . . .

"Guide to Inspections of:

• Biotechnology
• Computer Issues
• Devices
• Drugs
• Foods & Cosmetics
• Miscellaneous

Note: These documents are reference material for investigators and other FDA personnel. The documents do not bind FDA and do not confer any rights, privileges, benefits or immunities for or on any person(s). An alternative approach may be used if such an approach satisfies the applicable statutes, regulations or both."

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