Experts examined the FDA’s enforcement actions from the first part of 2026, and one of their key takeaways is that the agency is actively enforcing current Good Manufacturing Practice (CGMP) compliance. More specifically, “recalls alone do not satisfy the FDA’s remediation expectations; companies must demonstrate comprehensive, root-cause corrections.”
This article will take a deeper look at the enforcement record and explain why in-house microbial testing is becoming a must-have for food, dietary supplements, botanicals, and natural products manufacturers.
A recall is not remediation
Regulators expect deviations to happen, but a voluntary recall is not enough. The FDA enforcement record shows that manufacturers must identify the root cause of a deviation and implement a Corrective and Preventive Action (CAPA) plan that prevents it from happening again. This expectation applies to dietary supplement and food manufacturers under 21 CFR Part 111.
The following companies recalled contaminated product, but the FDA still cited them for failing to demonstrate a comprehensive, root-cause-based response.
- Superfoods, Inc. (dba Live it Up) recalled its Super Greens dietary supplement powder in January 2026 after a multistate Salmonella outbreak traced to contaminated moringa leaf powder. By the time the investigation closed, the outbreak had reached 131 illnesses and 36 hospitalizations across 35 states. FDA’s traceback found a common raw-material supplier linked to a second recalled product line, and stated it was working with the firms involved “to determine a root cause of the contamination”.
- Nutratech, LLC received a warning letter citing failures under 21 CFR Part 111 Subpart D for equipment and utensils, and for master manufacturing records missing the required control points. FDA reviewed the firm’s CAPA report and found its corrective actions didn’t establish adequate product specifications, including microbial limits. The FDA’s review concluded the company’s root-cause response was incomplete.
- Nature’s Elements, Inc. was cited for failing to establish product specifications for the identity, purity, strength, and composition of several botanical supplements, including limits on contaminants that could adulterate the finished product, as required by 21 CFR 111.70(e). Without those specifications in place, the manufacturer has no baseline to measure a contamination event or its root cause.
How In-House Testing Protects Manufacturers
Prevention, Not Just Detection
Contract lab testing is constrained by cost-per-sample and turnaround time. Many manufacturers test at the minimum required checkpoints (i.e., at release).
In-house testing’s lower cost-per-sample and faster turnaround times make it feasible to test at multiple points:
- Raw material intake
- In-process bulk
- Across a production run
- Frequent environmental monitoring
More frequent testing means manufacturers can catch a contamination event while it’s still small, rather than after it’s reached a finished lot that has to be pulled from the market.
Builds a Root-Cause Dataset
A manufacturer testing only at release has one data point per batch. If that result comes back positive, they’re guessing whether the source was raw materials, environment, equipment, or process. A manufacturer testing at multiple in-process stages has a timeline. They can point to the exact stage where bioburden appeared, significantly narrowing the scope of the investigation.
This enforcement approach applies across all the FDA’s product categories. Without understanding where an issue arose any corrective action will be incomplete and preventive actions will be speculative.
Frequency of testing is what generates that understanding, and in-house testing is what enables frequent testing.
