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The FDA started enforcing Good Manufacturing Practice requirements for all Dietary Supplement manufacturers in 2010. Since then, they have published the results of their inspections and the warning letters they issue when manufacturers fail to come into compliance. For example, last July the FDA found a dietary supplement manufacturer, so far out of GMP compliance, they issued them this Warning Letter and sought an injunction to stop their manufacturing. This got us wondering about what does the FDA think are the most important compliance issues.

Our research turned up 7 of the main issues the FDA found in their inspections that wound up in Warning Letters to dietary supplement manufacturers. The problems we found were supported by statements made by FDA. In an article in the Chicago Tribune, Daniel Fabricant, head of the FDA’s Division of Dietary Supplement Programs said “It’s down right scary. At least half of [the dietary supplement] industry is failing on its face.”

The FDA enforces the Dietary Supplement Health and Education Act (DSHEA) law by inspecting dietary supplement manufacturers, packagers, labelers and holders for Current Good Manufacturing Practices (cGMPs) compliance. Their inspections are increasing every year and they have published the results on their website. 50% of dietary supplement manufacturers are not in GMP compliance and 1 in 4 dietary supplement companies have received a warning letter which could result in a significant enforcement action such as halting production and distribution.

A review of the warning letters published by the FDA reveled the most commonly cited violations of Good Manufacturing Practices at Dietary Supplement manufacturers. These were:

  1. Inadequate documentation of GMP procedures
  2. Master Manufacturing Records were not created
  3. Batch production records had inadequate information or didn’t follow the master
  4. No documentation that specifications were set
  5. No process control because of inadequate in-process specifications
  6. Deviations occurred without corrective action or documentation
  7. Suppliers and vendors were not qualified

We want to bring these to your attention and describe how each of these issues can easily be addressed. A multi-part GMP Compliance Series will be posted in this blog. These blogs will dig into the actual violations cited by the FDA in the warning letters issued to dietary supplement producers and what you can do check or improve your compliance.

Part 1: Improving Documentation of GMP Procedures

Part 2: Better Compliance through Master Manufacturing Records
Part 3: Improving Batch Production Records
Part 4: Specifications That Improve Compliance
Part 5: Improving Quality through In-Process Control
Part 6: Documenting Deviations for Improved Compliance
Part 7: Supplier and Vendor Qualification

We hope our blog articles will help you review your own situation and think about some of the ideas we will provide for improving your GMP for Dietary Supplement manufacturing.


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