# FDA WARNING_LETTER - Clientele, Inc. - February 07, 2020

Source: https://www.keypedia.com/records/warning_letter/clientele-inc/48eb845a-0af6-486c-ab2b-4dfec0ec608d

> FDA WARNING_LETTER for Clientele, Inc. on February 07, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Clientele, Inc.
- Inspection Date: 2020-02-07
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations II
- Summary: 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

## Related Documents

- [483 - 2020-02-07](https://www.keypedia.com/records/483/clientele-inc/6d6d5a2c-f289-4e85-9078-29a861ca7fe7)

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/monica-r-maxwell/e1b3373a-80b0-4023-9aea-b4ac7170c964)

Company: https://www.keypedia.com/companies/clientele-inc/d95e4d7a-c7d6-4773-b7d5-01ede0859d11

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-ii/930d696b-0ac7-4de4-8268-e3db00525bc6