FDA WARNING_LETTER - Strukmyer LLC - August 01, 2024

The FDA inspected Strukmyer LLC dba Strukmyer Medical (FEI 3000205837) in Mesquite, TX, from July 8 to August 1, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate over 60 instances of objectionable microbial contamination (e.g., Burkholderia, Pseudomonas, Staphylococcus, Bacillus, Aspergillus) in their water system used for OTC drug products, including those for wounds and burns. A previous recall in 2020 for Burkholderia cepacia contamination was noted. The firm's response was deemed inadequate for failing to identify root causes and assess the impact on distributed products. 2. **Insufficient Component Testing (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm failed to adequately test incoming component lots, specifically glycerin, for identity and conformity, including for diethylene glycol (DEG) or ethylene glycol (EG) contamination, and relied on supplier COAs without validation. The firm's proposed testing frequency was inadequate, and