# FDA 483 - All Pharma, LLC - November 15, 2019

Source: https://www.globalkeysolutions.net/records/483/all-pharma-llc/574b3884-a273-4854-8e55-d2c5678cdc34

> FDA 483 for All Pharma, LLC on November 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: All Pharma, LLC
- Inspection Date: 2019-11-15
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: All Pharma, LLC, an OTC drug manufacturer and prescription drug relabeler in Hialeah, FL, received a Form 483 with significant observations. The inspection revealed critical failures in the quality control unit, including inadequate material release, insufficient investigation of out-of-specification results, and a deficient change control system. Additionally, issues with facility changes and unsuitable equipment surfaces were noted, indicating a broad lack of adherence to cGMP regulations.

## Related Officers

- [Jennifer Lalama](https://www.globalkeysolutions.net/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.globalkeysolutions.net/companies/all-pharma-llc/99218d35-8eb9-40af-b0f1-381af10ff3da

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