FDA WARNING_LETTER - Cerno Pharmaceutical - November 17, 2017

The FDA inspected Cerno Pharmaceuticals, LLC from November 13-17, 2017, identifying significant CGMP and misbranding violations, rendering their drug products adulterated and misbranded.

CGMP violations include: 1. **Failure to withhold components:** The firm used salicylic acid (lot (b)(4)) for Verruguin Wart Remover production before testing and quality unit release, stating they manufactured "at risk." The response to create a deviation report and train staff was deemed inadequate; the FDA requires analytical results for used components and preventative measures. 2. **Inadequate cleaning procedures:** The firm failed to follow its own cleaning procedure (CP-QA-015), performing a minor (dry) cleaning on July 31, 2017, when a major (wet) cleaning was required due to a gap exceeding two months since the last major clean. The response was inadequate for not assessing product quality impact or defining "extended period of time." The FDA requires a revised procedure, training, and enforcement plan. 3. **Failure to maintain adequate equipment records:** The firm lacked proper equipment use logs for the blender and filler, using combined "Room/Equipment Cleaning and Use Logs" that were incomplete and unclear. The provided logs were unacceptable. The FDA requires revised logs with complete information and controls to ensure proper use.

The FDA strongly recommends engaging a qualified CGMP consultant.

Misbranding violations for Verruguin