PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Form 483 issued August 2, 2023 · Greenville, South Carolina
- Inspection
- Jul 24 – Aug 2, 2023
- Observations
- 2
- Pages
- 3
- FEI number
- 1017687
In short: On August 2, 2023, FDA issued a Form 483 with 2 observations to PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma in Greenville, South Carolina (FEI 1017687) after an inspection that ran Jul 24 – Aug 2, 2023. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written production and process control procedures are not followed in the execution of production and process…
- 02
Written procedures for cleaning…
This inspection in context
Questions about this 483
What did FDA find at PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma inspected by FDA?
The inspection ran Jul 24 – Aug 2, 2023, and the Form 483 is dated August 2, 2023.
How do I get the full Form 483 for PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.