# FDA 483 - PAI Holdings, LLC, dba Pharmaceutical Associates, Inc - September 02, 2022

Source: https://www.globalkeysolutions.net/records/483/pai-holdings-llc-dba-pharmaceutical-associates-inc/6938858a-0ca4-44c0-a078-a4f6939e8a57

> FDA 483 for PAI Holdings, LLC, dba Pharmaceutical Associates, Inc on September 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PAI Holdings, LLC, dba Pharmaceutical Associates, Inc
- Inspection Date: 2022-09-02
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: VistaPharm, Inc. in Largo, FL, a drug manufacturer, was inspected and cited for significant deficiencies across three observations. The inspection revealed inadequate production and process controls for Clobazam Oral Suspension, unsanitary conditions due to vermin infestation in manufacturing areas, and failures within the quality control unit regarding Annual Product Reviews, finished product labeling, and good documentation practices. These issues indicate a lack of adherence to cGMP regulations.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/pai-holdings-llc-dba-pharmaceutical-associates-inc/ced132fd-1cf6-46e4-9ca3-1730248290b7)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)
- [Damaris Y. Hernandez](https://www.globalkeysolutions.net/people/damaris-y-hernandez/ca16093e-047b-4bf1-bcc1-c439cff21e8a)
- [Investigator ](https://www.globalkeysolutions.net/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.globalkeysolutions.net/companies/pai-holdings-llc-dba-pharmaceutical-associates-inc/8c0bd848-8106-4ffb-9eac-4202f50a39ab

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