Clientele, Inc. – FDA Warning Letter, Feb 7, 2020

The FDA inspected Clientele, Inc.'s drug manufacturing facility from February 3-7, 2020, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products "Age Blocker" and "Estro-Lift Day Therapy" adulterated under 21 U.S.C. 351(a)(2)(B). The products are also misbranded under 21 U.S.C. 352(c), and "Age Blocker" is further misbranded under 21 U.S.C. 352(a).

Key violations include: 1. **Inadequate Quality Unit (QU):** Failure to establish an adequate QU with written, followed procedures (21 CFR 211.22(a) and (d)). The QU did not provide sufficient oversight for OTC drug manufacturing. 2. **Lack of Process Validation:** Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a)), specifically lacking process performance qualification (PPQ) studies and validation of in-process hold times. An example cited was "Age Blocker" lot Q09108, where bulk product was stored for extended periods with insufficient microbiological testing. 3. **Inadequate Laboratory Controls:** Failure to establish scientifically sound controls for water systems (21 CFR 211.160