FDA WARNING_LETTER - Higley Industries, Inc. - September 21, 2023

The FDA inspected Higley Industries, Inc. (FEI 3002984417) in Dyersville, IA, from September 19-21, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Failure to test components:** The firm did not adequately test incoming ethanol for methanol or high-risk components like glycerin for diethylene glycol (DEG) or ethylene glycol (EG) contamination, relying on supplier COAs without validation. They also failed to demonstrate their water system's suitability for drug manufacturing. The company's response regarding third-party testing and water quality monitoring was deemed inadequate due to a lack of detail on establishing reliability. 2. **Inadequate production and process controls:** The firm failed to validate processes and qualify equipment for manufacturing PSSI E-SAN Alcohol Antiseptic 80% Topical Solution Hand Sanitizer. Their response acknowledging this and committing to validation was insufficient, lacking detail and evidence of implementation. 3. **Inadequate quality control unit (QU) oversight:** The QU failed to ensure CGMP compliance, including reviewing and approving production records, providing oversight, and conducting complete batch reviews before release. The company's updated QU procedures were deemed inadequate without sufficient detail or evidence of implementation.

The FDA recommends engaging a qualified CGMP consultant to evaluate operations and assist with compliance,