PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Form 483 issued August 20, 2015 · Greenville, South Carolina
- Inspection
- Aug 10 – Aug 20, 2015
- Investigators
- Bonita S. Chester· Joseph F. Owens
- Observations
- 2
- Pages
- 2
- FEI number
- 1017687
In short: On August 20, 2015, 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 Aug 10 – Aug 20, 2015. The investigators were Bonita S. Chester and Joseph F. Owens. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…
- 02
Written procedures have not been developed for the surveillance, receipt, evaluation, and reporting to FDA of…
This inspection in context
Bonita S. Chester
17 documents · 2013–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmPAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 314.80(c)(1)(i)
See how FDA wrote the same problem up elsewhere.
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. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma?
Bonita S. Chester and Joseph F. Owens are named on this Form 483, for the inspection of Aug 10 – Aug 20, 2015. Each investigator has a profile showing what they cite most.
When was PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma inspected by FDA?
The inspection ran Aug 10 – Aug 20, 2015, and the Form 483 is dated August 20, 2015.
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.