20resourcesFDA inspections.  If you find yourself googling FDA inspector names, if you see your boss’s new Porsche parked in the parking lot with a license plate that says, “Zero 483s” (true story), then part of your job includes preparing your facility to be ready at any second for an FDA inspection.

This post is for you.  Here are our top 20 resources and FAQs for you:

FDA inspections 101

  1. What does the FDA inspect?  The FDA inspects all “manufacturers or processors” of FDA-regulated products – this includes these kind of manufacturers: vaccine and drug manufacturers, blood banks, food processing facilities, dairy farms, and animal processors.  The objective of these inspections are to ensure that they comply with all relevant regulations.
  2. What are the 3 types of FDA inspections. If you’re new at this, it’s important to understand the 3 basic reasons an FDA inspector is conducting the inspection.
  3. What are cGMP regulations?  cGMP stands for “current good manufacturing practices” and are laid out in Title 21 of the Code of Federal Regulations.  A web-friendly version of these regulations have been created at leanbiotech.com
  4. How often does the FDA inspect facilities?  Chances are, the FDA is at at least one facility right now. Based on the number of FDA 483s that the FDA issues (approximately 10,000 per year), theFDA initiates an inspection resulting in a 483 every 50 minutes.  The FDA also published that they conducted at least 17,000 inspections in 2010, translating to about one inspection every 30 minutes.  UPDATE: we now have recent data that says the FDA conducted 40,000 inspections in 2012.
  5. What paperwork does the FDA process as part of the inspection itself?  The FDA issues what’s called a 482 report each time they inspect a facility. These reports simply verify that an inspectionhas taken place and includes basic information such as manufacturer company, representative, address, date, time, and inspector name/signature. An example of this 482 can be found here (PDF).
  6. What do we do after the FDA completes the inspection?  If the FDA investigator observes anything that could be out of place, they notate it in the FDA 483 report. These reports are simply inspectional observations, and do not represent a final agency determination.  If you do receive an FDA 483, you should respond swiftly and comprehensively. For more on how to respond to an FDA 483, visit this article from FDAzilla.
  7. Is the FDA increasing or decreasing attention on this area?  Definitely increasing.  Inspectionsand 483s have been trending up in recent years.  Our research shows that 483s hit all-time highs for each of the last three years, topping 10,000 FDA 483s in 2011.  A quick glance at the observation summary reports from #9 above show a steady increase in the number of inspections as well – 14k+ in 2008, 15k+ in 2009, and then 16k+ in 2010.  Within the drug category, we saw 400+ in 2008, 500+ in 2009, and 600+ in 2010.
  8. List of searchable FDA inspections – cGMP has put together a great, searchable list of all FDA inspections since October 2008.  You can search by company, year, or city. Alternatively, you can purchase the entire list of 2012 FDA inspections & 483s in Excel Format in our store.

Resources for Quality & Regulatory Managers and Directors responsible for preparing facilities for inspection.

  1. Learn from others’ 483s.  The best learnings often come from other people’s mistakes.  The best place to study these mistakes in a systematic manner is other facilities’ FDA 483 reports.  Go to FDAzilla’s 483s store that consists of 1,000+ 483 reports in PDF format, available for immediate purchase and download.  If you can’t find the FDA 483 you’re looking for, your best bet may be to request it from the FDA itself via FOIA.
  2. Google the inspector’s name (first-name last-name FDA inspector).  Chances are, you will land on the same FDAzilla store of 483s, only this time, you’ll get a list of all 483s that this particular inspector has been a part of.
  3. FDA 483s Resource Center. This has some of the best links around 483s – everything from intro-level information (if you’re new to all this craziness) or if you are looking for specific 483 intelligence.
  4. FDA INSPECTIONS Linkedin Group.  This group is active, has 16,000+ members, and have decent conversations occurring on an on-going basis.
  5. Acing FDA inspections and Avoiding 483s REPORT (coming soon!).  We read a ton of FDA 483s and found some trends. This is a great data-driven report on the 7 key things to prepare for before anFDA inspection.  Also includes some great charts on FDA 483 trend data as well as some of the companies that seem to be the FDA favorite targets.  All you need to access it is your email address.
  6. Free email newsletter on pharma manufacturing.  This includes other areas beyond FDAinspections, but is one of the best free industry email newsletters I’ve seen. 28,000+ are already on this list.
  7. FDA’s Inspection Guides.  Though these are somewhat dated, they are obviously authored by theFDA. They are intended as a reference for FDA investigators and other FDA personnel.  Even if they don’t go with these plans, obviously it’s good to read what they’ve been reading, no?
  8. FDA’s Investigations Operations Manual. Another internal document meant for FDA investigators and FDA inspectors.
  9. FDA’s Inspection Observation Summaries. The FDA provides summary data of the “most frequent observations” in this page.  Though it only represents ~60-70% of all 483s (our estimate), it provides a good list to watch out for.  For example, the most frequently cited phrase in 2010 is “maintained and followed” – i.e. there were written procedures that are correctly in place for a certain process, but these procedures were not maintained or followed.  Other frequent flyers in 2010 from these FDA inspectionsinclude: thorough investigations, person performing, test results, interpretation, required reports, and concurrent documentation.
  10. FDA’s Inspection Database.  The FDA releases new data into his inspection database approximately every half year.  The current inspection database lists all inspections from 10/1/2008 to 3/31/2012 – a span of 3.5 years.  Due to how the FDA stores this data, one inspection may be listed within this spreadsheet multiple times. For example, one inspection may be listed 3 times – once under the CDER department / Drug Quality Assurance Project, once under the CDER department / New Drug Evaluation Project, and once under the CVM department / Monitoring of Marketed Animal Drug, Feed, and Devices Project. For the FDA data, this inspection on one date at one facility represents 3 rows in the spreadsheet.
  11. Annual FDA Inspections Summit.  Put on by FDAnews.com, this annual conference (usually in the fall) typically features 3 or 4 speakers who are key compliance and/or inspection leaders within theFDA giving updates about FDA policies and procedures.  Other speakers include numerous experts in the field.  Some of the most crucial content covered at the event are recent changes in FDAinspection policies and processes.  For example, as FDA investigators become more trained in data mining (think about your AER data), they may begin asking for data, digesting it in the evenings, and coming back in the morning with specific questions.
  12. When the FDA is at your site, watch your attitude.  As this author aptly eludes, some mental preparation is needed to get yourself in a positive mindset.  Yes, they’re there essentially to criticize you.  Remember – they’re just doing their jobs.  They’re people, too.  Your best bet is still to remain positive, build positive/professional rapport with them, and let your preparation do the talking.

What have you found to be particularly useful in dealing with and managing FDA inspections?  Feel free to comment below.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence.

by Tony Chen