# FDA 483 - PAI Holdings, LLC, dba Pharmaceutical Associates, Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/pai-holdings-llc-dba-pharmaceutical-associates-inc/ced132fd-1cf6-46e4-9ca3-1730248290b7

> FDA 483 for PAI Holdings, LLC, dba Pharmaceutical Associates, Inc on Unknown Date. 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
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Vista Pharm, a manufacturer and re-packager of drug products in Largo, FL, was cited for significant deficiencies during an FDA inspection. Observations included failures in written procedures for cleaning and maintenance, specifically regarding sampling point identification, documentation of activities, and timely completion of maintenance. Additionally, the firm failed to follow established test procedures and laboratory control mechanisms, leading to issues with sample protection and microorganism identification.

## Related Documents

- [483 - 2022-09-02](https://www.globalkeysolutions.net/records/483/pai-holdings-llc-dba-pharmaceutical-associates-inc/6938858a-0ca4-44c0-a078-a4f6939e8a57)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

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