Whether we like it or not, FDA inspections are a reality of the supplement manufacturing industry. Always has been, always will be, and rightly so because after all, this industry is all about people’s health and safety. And eventually, that’s what you, as a supplement business owner, want to provide for your customers through the products you offer.
So, the question you need to ask yourself is whether your supplement contract manufacturer is ready for an FDA inspection.
FDA at the door – is your supplement manufacturer ready?
There’s no denying the fact that the FDA has been tightening its position with respect to inspections and enforcement of its guidelines.
The key to a successful FDA inspection is preparedness. A lot of FDA inspections are scheduled in advance, but it’s possible that your supplement manufacturer may not get a lot of lead time to prepare for it. If you think that’s scary, let me tell you that the inspectors may also just show up at their door one fine morning unannounced.
Whether you’re a startup or an established supplement business owner, you need to make sure you’ve partnered with a manufacturer who is fully cGMP-compliant. Here’s a checklist to go through with your contract nutraceutical manufacturer.
Checklist to prepare for an inspection
I came across a whitepaper that has extensive information on FDA inspections for food and dietary supplement businesses. Before I share some pointers from there, here are a few things for your supplement manufacturer to keep in mind:
- Be hospitable, warm and as cooperative as possible. While it’s not rude to ask for identification, it is definitely not required to be defensive or impatient when answering questions.
- Provide them a designated area, preferably a conference room, where they can review/stamp documents without any disruption.
- Instruct your staff to assist them with all their needs. If possible, assign a team of people to help the inspectors find what they’re looking for.
Now for the checklist I had referred to earlier. Remember, these are things your supplement manufacturer can do to prevent an adverse outcome, but they don’t guarantee a positive result.
- Make sure all product labels comply with federal regulations. Avoid using problematic claims/ language on product labels and make sure all the required content is properly displayed on the labels.
- Make sure your contract supplement manufacturer complies with all the applicable Good Manufacturing Practice or GMP regulations. Here are the top five GMP violations for dietary supplements:
- Failure to prepare a Master Manufacturing Record
- Failure to prepare a Batch Record
- Failure to establish specifications
- Failure to determine if specifications are met
- Failure to establish adequate quality control
- Make sure that their facility is in top sanitary condition. There’s nothing more off-putting for an FDA inspector than to see a facility that’s not up to its standards of cleanliness and hygiene. Don’t forget to calibrate all your equipment before the inspection starts.
- If your manufacturer has any pending complaints against them or has been required to recall products, they should be prepared to discuss them with the FDA inspector. Inspectors are likely to focus on these events, so they should be willing to share all the required information with the FDA and update them on follow-up actions.
- It is mandatory for companies to have standard operating procedures or SOPs governing FDA inspections of their facility. SOPs should include clear instructions for all parties involved in an FDA inspection – from receptionists to senior management and ownership. All employees should be trained in SOPs.
- Your supplement manufacturer should determine the records that the FDA is likely to want to review and make sure these can be made readily available to them. The last thing anyone would want is to answer more pointed questions while the inspectors wait for the requested documents to arrive.
- Has your supplement manufacturer appointed a person on staff who has contact information of all the third parties who could provide relevant and helpful information to the FDA? These third parties include your lawyer, equipment manufacturer, ingredient supplier, etc.
These are seven simple rules to a successful FDA inspection. For a variety of reasons, many manufacturers have been unable to or unwilling to comply with the FDA cGMPs; don’t let it be YOUR supplement manufacturer. Make sure they’ve got their act together BEFORE the inspection. If you need help more help, read through the FDA Guidelines for cGMPs. And here’s another tip in case you’re doubtful about your current supplement manufacturer will survive an FDA inspection.
Use a Third-Party GMP-Certified Contract Supplement Manufacturer
In an article featured by Vitamin Retailer on “The Importance of GMP Compliance”, Jason Provenzano of Nutricap Labs said, “From when we first started Nutricap Labs in 2003, we knew there had to be a standard set in the industry and wanted to ensure our customers would always receive the highest quality product. All of Nutricap Labs’ supplement contract manufacturing services are completed in a state-of-the-art facility that holds both GMP certification from NSF and TGA certification from the Australian government.” Third-party certifications are essential to doing not just good business, but providing excellent contract manufacturing services.
Like Nutricap Labs, many other companies recognized the importance of being GMP-certified by third parties like the NSF long before FDA introduced its cGMPs. If you’re a retailer looking for a contract manufacturer, go through the checklist above with your prospective manufacturer and make sure they work within a third-party GMP-certified facility. And if you need help choosing the right manufacturer follows these tips on How to Choose a Contract Manufacturer.
Make sure your supplement manufacturer is ready to roll out the red carpet to your friendly neighborhood FDA inspector. Why? Not only does your business depend on it, but your customers rely on it, too.