FDA 483 - RLC Labs Inc. - March 05, 2020

RLC Labs Inc. in Phoenix, AZ, a drug product manufacturer, was inspected and found to have significant deficiencies across its quality system, production, and material controls. The firm lacks a functional quality control unit, proper stability testing, validated specifications, and adequate complaint handling, indicating a broad failure to adhere to GMP regulations. These issues raise concerns about the identity, strength, quality, and purity of its drug products, including Nature-Throid and WP Thyroid.