FDA Flags CGMP Violations at Strukmyer LLC

The FDA inspected Strukmyer LLC (July 8 – Aug. 1, 2024) and identified serious CGMP violations, rendering products adulterated under the FD&C Act.

Key Violations

1. Microbial Contamination (21 CFR 211.192)
• Burkholderia, Pseudomonas, Staphylococcus found in water used for OTC products.
• No root cause analysis or corrective actions despite a 2020 recall.
2. Failure to Test Glycerin (21 CFR 211.84)
• No identity and impurity testing (e.g., diethylene glycol).
• Reliance on unverified supplier certificates.
3. Inadequate Cleaning (21 CFR 211.67(a))
• No proof of eliminating fungi & bacteria.
4. Quality Control Deficiencies (21 CFR 211.22(a))
• QU failed to validate test methods.

FDA Demands

• Hire a CGMP consultant & submit a corrective plan in 15 days.
• Non-compliance may lead to seizures or production halts.

17-03-2025