How your quality processes are going, or not going, and you have a recipe for FDA 483 observations or worse, FDA Warning letters 2021.

1. FDA 483 Observations vs. Warning Letter
Companies in the life sciences, food, and cosmetics industries are all too
aware of how fickle the market is, how dynamic their studies and those
under investigation are, as well as their timelines for releasing a specific
medical device or medication. Adding to that, how your quality processes
are going, or not going, and you have a recipe for FDA 483 observations or
worse, FDA Warning letters 2021.
How do companies get to this point? What are the differences? How does a
company avoid them?
I’ve worked with life-science-related companies for eight years now. When
I first started in this vertical, I had no idea what these terms meant or their
impact. I quickly learned that the FDA published an email indicating which
companies had been cited, including names of the executives, location, and
details about their citing. This is terrible news, especially for their
patients/customers and employees! Think of the ramifications! You do NOT
want to be on either of these FDA lists!

2. The difference between a 483 FDA observation and a Warning Letter is
as follows….
483 Observation – A notice that indicates potential regulatory problems.
The first inspection team issues this.
Warning Letters – An escalation of the previous FDA audit 483
observations. It’s issued from a higher level of an FDA official.
Based on the FDA’s website:
“Make sure everything is written down: all procedures, activities, protocols,
etc. Avoid a paper-based system as this is hard to track. Simplify SOPs and
maintain and update them regularly. Ensure staff are well trained on
company procedures and have a sound understanding of manufacturing
practices like GMP.”
The FDA has even More details here as well…
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-
investigations/inspection-references/fda-form-483-frequently-asked-
questions
In my early years of life sciences, I would call and get calls from individuals
at companies. Fortunately, we had consultants (and currently do now) who
knew how to remediate these scenarios with efficiencies. This would allow
the company to get back on track and stay “above board” when meeting
compliance.
The simplistic approach is always to have someone monitoring the
regulations and compliance expectations and make sure everyone else
knows about them. Keeping a Quality manual up to date and making certain
employees are trained against them (marketing and sales too) is
preventative medicine.
I remember when an Ebola case had broken out again, around 2014. There
was a “sales rep” of an essential oil company who had posted on their blog

3. and was telling people verbally that one of their oils “prevented Ebola.” Uh
oh! Someone in the FDA caught wind of the blog. Suddenly, the company
was given an FDA 483 form. Thanks to One person, it took a good six
months or more to iron all of that out.
In a nutshell (inspected by the FDA, of course ), set up procedures with
documentation that can be easily accessible to everyone, and trained and
retrained against regularly. You also need a resident expert or two on staff
or on call to keep everyone informed of new changes. For the sake of your
patients, customers, and employees, you need to stay ahead of the game
and avoid FDA 483s and Warning Letters.
Connect with Compliance Group today at sales@complianceg.com or
call (847) 327-3167, Ext. 406.
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