# FDA 483 - LiquidCapsule Manufacturing, LLC - July 03, 2025

Source: https://www.globalkeysolutions.net/records/483/liquidcapsule-manufacturing-llc/88614add-0f87-4689-a358-957c5b98d916

> FDA 483 for LiquidCapsule Manufacturing, LLC on July 03, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LiquidCapsule Manufacturing, LLC
- Inspection Date: 2025-07-03
- Product Type: drugs
- Office Name: Florida District Office
- Summary: LiquidCapsule Manufacturing, LLC, an OTC drug manufacturer in Tampa, FL, was cited for significant deficiencies during an FDA inspection from June 25 to July 3, 2025. The firm failed to establish adequate production and process controls, including process validation and equipment qualification, and exhibited critical issues with cleaning validation and procedures. Additionally, the inspection revealed non-contemporaneous batch records, a lack of an ongoing stability program, inadequate component identity testing, and a quality control unit that did not fully follow its responsibilities or ensure cGMP compliance.

## Related Documents

- [WARNING_LETTER - 2014-10-20](https://www.globalkeysolutions.net/records/warning_letter/liquidcapsule-manufacturing-llc/b4d75e4c-8a90-47c3-a856-1f809582253c)
- [483 - 2024-02-09](https://www.globalkeysolutions.net/records/483/liquidcapsule-manufacturing-llc/2e3d13c5-3ffd-43f6-b9bd-41710ce1428d)
- [WARNING_LETTER - 2025-07-03](https://www.globalkeysolutions.net/records/warning_letter/liquidcapsule-manufacturing-llc/cab202cd-2826-424f-bd85-175f7828b0f7)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

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

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9