Solvay USA LLC
Form 483 issued November 13, 2015 · Spartanburg, South Carolina
- Inspection
- Nov 9 – Nov 13, 2015
- Investigators
- Bonita S. Chester· Jason K. Morgan
- Observations
- 8
- Pages
- 4
- FEI number
- 1000110782
In short: On November 13, 2015, FDA issued a Form 483 with 8 observations to Solvay USA LLC in Spartanburg, South Carolina (FEI 1000110782) after an inspection that ran Nov 9 – Nov 13, 2015. The investigators were Bonita S. Chester and Jason K. Morgan. Most observations concern laboratory controls and materials.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to conduct identity testing of the API (active pharmaceutical ingredient) starting material, IGEPAL CO-630, used…
- 02
Failure to demonstrate that process water used in the manufacture of API products is suitable…
- 03
Failure to ensure that access to label issuance software is limited to…
- 04
Failure to ensure computerized systems have sufficient controls to prevent unauthorized access…
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 firmSolvay USA LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Solvay USA LLC?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, materials and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Solvay USA LLC?
Bonita S. Chester and Jason K. Morgan are named on this Form 483, for the inspection of Nov 9 – Nov 13, 2015. Each investigator has a profile showing what they cite most.
When was Solvay USA LLC inspected by FDA?
The inspection ran Nov 9 – Nov 13, 2015, and the Form 483 is dated November 13, 2015.
How do I get the full Form 483 for Solvay USA LLC?
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.