If you make it, they will come!
They being the FDA that is… If you manufacture, package, or label drugs or dietary supplements, you will see the FDA at some point. I have had clients who didn’t think they had to comply if they manufactured the products but someone else packaged and labeled them. I’ve had the opposite too where someone who bought bulk tablets and capsules, then packaged and labeled them didn’t think they needed to comply because they were not manufacturing them. Well, both companies need to comply!
Typically, GMP inspections take place every two years. Drug companies are used to seeing the FDA, but Dietary Supplement companies are new to this. Just to refresh everyone’s memory, supplement companies with more than 500 employees had to be in compliance with the supplement GMP’s, 21 CFR Part 111, by June 25th of 2008. The FDA has been out inspecting these companies and several EIR’s, along with their 483’s are on the FDA’s website. Go to http://www.fda.gov/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/default.htm You’ll need to navigate through them to find the supplement ones, but there is some interesting reading there.
This past June 25th, companies with 20-500 employees had to be in compliance with Part 111. A couple of my clients have already seen the FDA at their facility so that’s proof that FDA is out on the job. So, anyone that didn’t think this was real or that FDA wouldn’t be able to get these inspections done, think again! As I said earlier, if you make it, they will come.
Next June 25th, companies with fewer than 20 employees hit their compliance deadline. My hope is that every company making supplements reads the regulations, apply them to their organization, and be ready when the FDA shows up at your facility.
If you are wondering if you are ready or not, no worries! Techceuticals can definitely help. Contact me at carol@techceuticals.com or give me a call at 843-815-7441 and I will be happy to help answer your questions and provide you with the help you need.
Until next time, have a quality day!
Carol (Brennon) Tousey, ASQ CQA
Posted by Mike on October 2nd, 2009 :: Filed under cGMP's
Tags :: compliance, Dietary Supplements, drugs, gmp compliance, GMP's, regulatory compliance assistance