# FDA 483 - Clientele, Inc. - February 07, 2020

Source: https://www.globalkeysolutions.net/records/483/clientele-inc/6d6d5a2c-f289-4e85-9078-29a861ca7fe7

> FDA 483 for Clientele, Inc. on February 07, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clientele, Inc.
- Inspection Date: 2020-02-07
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Clientele, Inc., an OTC drug manufacturer in Sunrise, FL, was cited for significant deficiencies across its quality control, laboratory controls, stability testing, equipment management, and production processes. The inspection revealed a lack of cGMP systems, inadequate testing procedures for finished products, and insufficient validation for equipment and manufacturing processes. These issues indicate a systemic failure to ensure drug product quality and purity.

## Related Documents

- [WARNING_LETTER - 2020-02-07](https://www.globalkeysolutions.net/records/warning_letter/clientele-inc/48eb845a-0af6-486c-ab2b-4dfec0ec608d)

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.globalkeysolutions.net/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

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

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6