From Burkholderia to Ethylene Glycol - a List of Deficiencies at a Manufacturer of OTC Products

The U.S. Food and Drug Administration (FDA) inspected Strukmyer LLC's manufacturing facility from July 8 to August 1, 2024 and found significant violations of Current Good Manufacturing Practice (CGMP) for drug products. Due to these deficiencies, the manufactured products are considered adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
In addition to microbiological findings, the company joins a long list of Warning Letters with inadequate control of glycerin components. The following is a summary of the listed deficiencies.

1. Inadequate investigation of microbial contamination (21 CFR 211.192)

Between November 2022 and July 2024, microorganisms of concern (e.g. Burkholderia, Pseudomonas, Staphylococcus) were detected in the company's water treatment plant. This water was used to produce over-the-counter medicines for wounds and burns. Adequate investigation of the source of contamination (root cause analysis) and effective corrective actions (CAPA) are lacking. The company had already initiated a recall in 2020 due to microbial contamination.
The FDA is therefore demanding:

A comprehensive assessment of the microbiological hazards
A detailed risk assessment and planned measures
Complete testing of all affected batches
Improved microbiological testing procedures

2. Lack of identity and quality testing of ingredients (21 CFR 211.84)

The company failed to test components such as glycerin for identity and impurities (e.g. diethylene glycol, ethylene glycol). It relied on certificates of analysis from suppliers without regularly validating their reliability. The FDA emphasizes the high risk of harmful impurities and demands comprehensive testing strategies. The FDA expects:

• Identity tests for every batch
• Validation of the certificates of analysis from suppliers
• An independent review of the material system

3. Inadequate cleaning and sanitizing procedures (21 CFR 211.67(a))

The company could not demonstrate that its cleaning and sanitizing methods were sufficient to remove all contaminants from the production environment. Specifically, comprehensive testing for fungi and gram-positive bacteria was not performed. The FDA demands:

• Stricter microbiological limits for water
• Standardized validation procedures for cleaning

4. Insufficient quality control (21 CFR 211.22(a))

The company's quality unit (QU) failed to ensure validation of test methods by the contract laboratory. Analytical test methods for quality testing were not adequately reviewed. The FDA requires:

• An independent assessment of quality control systems
• Improve QU monitoring for laboratory procedures and testing

Recommendation to engage a CGMP consultant

The FDA strongly recommends that the company engage an external CGMP compliance consultant. A complete system review and sustained corrective action is required, and the consequences are noted.
The company has 15 working days to respond to this Warning Letter and initiate corrective measures. Failure to do so may result in legal consequences, including product seizures and production stoppages.

Further details can be found directly in the Warning Letter of the FDA.