# FDA 483 - PAI Holdings, LLC. dba Pharmaceutical Associates Inc - August 02, 2023

Source: https://www.globalkeysolutions.net/records/483/pai-holdings-llc-dba-pharmaceutical-associates-inc/10de477d-5448-4f04-952c-cb08bd0d77ea

> FDA 483 for PAI Holdings, LLC. dba Pharmaceutical Associates Inc on August 02, 2023. 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: 2023-08-02
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: PAI Holdings, LLC. dba Pharmaceutical Associates, Inc in Greenville, SC, was cited for significant deficiencies during an FDA inspection from July 24 to August 2, 2023. Observations included failures in equipment calibration, work order initiation for identified issues, and concurrent documentation practices. Additionally, the firm lacked adequate written procedures for cleaning and maintenance schedules, leading to conditions like rust on manufacturing equipment.

## Related Documents

- [483 - 2019-02-22](https://www.globalkeysolutions.net/records/483/pai-holdings-llc-dba-pharmaceutical-associates-inc/76795c6c-0b2b-4ada-904c-dc83f616601d)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)

Company: https://www.globalkeysolutions.net/companies/pai-holdings-llc-dba-pharmaceutical-associates-inc/b93f9b61-624a-4cd9-925c-039200bc1e79

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7