Vi-Jon, LLC – FDA Warning Letter, Oct 13, 2021

On March 31, 2022, the FDA issued a Warning Letter to Vi-Jon, LLC, following an inspection from October 4 to October 13, 2021, at their St. Louis, MO drug manufacturing facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products, including OTC hand sanitizers, adulterated. The FDA deemed the company's November 3, 2021, response to the Form FDA 483 inadequate.

Key violations include: 1. **Inadequate Laboratory Controls (21 CFR 211.160(b)):** The firm failed to establish scientifically sound specifications and test procedures for components, particularly concerning their water system used in non-sterile drug products. The water sampling plan was not representative, and *Burkholderia cepacia* (B. cepacia) was repeatedly detected in finished drug products, indicating insufficient water system monitoring and control. The firm lacked appropriate limits for B. cepacia in their water system and did not routinely test for it using validated methods.

2. **Failure to Establish and Follow Adequate Written Procedures for Cleaning and Maintenance of Equipment (21 CFR 211.67(b)):** Investigators observed multiple equipment leaks in the water purification system and a material transfer manifold, which were not properly documented or investigated by the quality unit. Rust was also noted in the laboratory'