Clinical Resolution Laboratory Inc. – FDA Warning Letter, Apr 27, 2021

On March 1, 2022, the FDA issued a Warning Letter to Clinical Resolution Laboratory Inc. following an inspection from April 6-27, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated. The letter also cited specific products, including “(b)(4)” and “(b)(4),” as unapproved new drugs and misbranded.

Key violations included: 1. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a)):** The firm lacked process validation data for OTC drug products and an ongoing program for monitoring process control. Their proposed retrospective validation was deemed inadequate, and a detailed process performance protocol and timeline for prospective studies were requested. 2. **Failure to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)):** Cleaning processes for non-dedicated manufacturing equipment were not validated, and microbiological testing methods for cleaning effectiveness were unvalidated. The firm's response was inadequate, lacking a comprehensive assessment and interim measures. 3. **Failure to have appropriate laboratory determination of satisfactory conformance to final specifications prior to release (21 CFR 211.165(a)):** Drug products were released before all quality control testing was completed and reviewed, a repeat observation from a previous inspection. A