# FDA 483 - LiquidCapsule Manufacturing, LLC - February 09, 2024

Source: https://www.keypedia.com/records/483/liquidcapsule-manufacturing-llc/2e3d13c5-3ffd-43f6-b9bd-41710ce1428d

> FDA 483 for LiquidCapsule Manufacturing, LLC on February 09, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LiquidCapsule Manufacturing, LLC
- Inspection Date: 2024-02-09
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: LiquidCapsule Manufacturing, LLC in Tampa, FL, was cited for significant deficiencies in its manufacturing and quality control processes for OTC drug products. The inspection revealed a lack of fundamental procedures, including process and cleaning validation, equipment qualification, and adequate quality unit oversight. These issues indicate a severe lack of control over product quality, identity, strength, and purity.

## Related Documents

- [WARNING_LETTER - 2014-10-20](https://www.keypedia.com/records/warning_letter/liquidcapsule-manufacturing-llc/b4d75e4c-8a90-47c3-a856-1f809582253c)
- [483 - 2025-07-03](https://www.keypedia.com/records/483/liquidcapsule-manufacturing-llc/88614add-0f87-4689-a358-957c5b98d916)
- [WARNING_LETTER - 2025-07-03](https://www.keypedia.com/records/warning_letter/liquidcapsule-manufacturing-llc/cab202cd-2826-424f-bd85-175f7828b0f7)

## Related Officers

- [Suzanne N. Vallez](https://www.keypedia.com/people/suzanne-n-vallez/7c16e0f4-c0b1-4f50-adfa-b1dc534694cd)

Company: https://www.keypedia.com/companies/liquidcapsule-manufacturing-llc/48ffd682-de13-45a1-a478-7b15ac580830

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