PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Form 483 issued February 22, 2019 · Greenville, South Carolina
- Inspection
- Feb 22, 2019
- Observations
- 4
- Pages
- 5
- FEI number
- 1017687
In short: On February 22, 2019, FDA issued a Form 483 with 4 observations to PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma in Greenville, South Carolina (FEI 1017687) after an inspection that ran Feb 22, 2019. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The quality control unit lacks authority to review production records to assure that no errors have…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
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 4 observations on this Form 483, mostly about quality system, production and materials. 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 Feb 22, 2019, and the Form 483 is dated February 22, 2019.
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.