Review Social Media Claims After GMP Inspection
Importance of facility cleanliness for safe products
FDA inspected this supplement manufacturer and marketer in November 2025 and issued some 483s related to sanitation and GMP documentation issues. The company then sent four 483 responses to FDA from December 2025 to May of this year. In May, apparently after the last 483 response, FDA reviewed the company’s social and website. They found disease claim-style claims that likely tipped-the-scale into a warning letter.
There are so many learning opportunities here.
FDA online review after inspection
Old social posts are “active” marketing
Incomplete 483 responses
GMP basics
And more!
Let’s start with the online claims. There’s been a trend over the past couple of years of FDA reviewing companies’ online claims, several months after the initial inspection. This may be around the time of the warning letter closeout, or in this case, after several incomplete 483 responses.
Old social posts are cited. Here’s one from 2018. A good reminder to review all posts for compliance concerns. A quick plug for Apex Compliance that scans captions and images on business Facebook, Instagram, and Amazon accounts. TikTok Shop is coming soon!
From warning letter. “[H]as been taking … for several weeks and has already noticed a drop in her daily glucose levels and fasting glucose levels. (from a post dated February 6, 2018)”
Implied and express disease claims. Avoiding cardiovascular biomarkers and diabetes claims is an essential part of compliance.
From warning letter. “Did you know Higher A1C levels are linked to diabetes complications? But did you also know that case reports have shown that … can help control post-prandial blood sugar levels?” Note: … is an ingredient in both the … products.
Sanitation issues. This showcases the importance of a sanitation sanity check to ensure the facility is protected from pests and areas where toxins like listeria can grow. I ran a supplement manufacturing company for years,, and I know that when everyone is going full speed every day, it is hard to take a step back and look at the facility through the eyes of FDA. This is why having a facilities manager who is supported by ownership is key to a safe facility
From warning letter. “Our investigator observed insulation hanging from the ceiling, one light casing which appeared to be taped with water leaking from it, two holes in your wall exposing outside elements, and multiple doors, including bay doors, with opening gaps allowing light to shine into your facility.
GMP paperwork issues highlight the importance of proper quality and operational oversight, meaning the operations manager should hold Quality accountable and vice versa.
From warning letter. “Your component specifications for (b)(4) had not been signed and approved by your quality control personnel.”
Incomplete 483 responses. The company seemingly had several chances to respond and “show their work.”
The full warning letter is worth a read.
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