FDA WARNING_LETTER - RLC Labs Inc. - March 05, 2020

The FDA inspected RLC Labs Inc. from February 20 to March 5, 2020, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm also failed to fulfill registration and listing obligations (21 U.S.C. 360(j)), leading to misbranded drugs (21 U.S.C. 352(o)). WP Thyroid® and Nature-Throid® products were found adulterated (21 U.S.C. 351(b)) for failing to conform to compendial standards for strength, quality, or purity, with six out of ten samples being sub-potent.

Key violations include: 1. **Inadequate Quality Control Unit (QCU) Oversight:** The QCU failed to review and approve written procedures for production and process control (21 CFR 211.100(a)). Process validation data for manufacturing and blending of APIs was missing, and critical equipment was not qualified. The firm's response was inadequate, lacking validation data, interim measures, a Master Validation Plan, protocols, and timelines. 2. **Insufficient Stability Program:** The firm lacked an adequate stability program for WP Thyroid and Nature-Throid, which have two- and three-year expiry periods (21 CFR