Stewart Compounding Pharmacy
Form 483 issued October 10, 2014 · Fayetteville, North Carolina
- Inspection
- Oct 6 – Oct 10, 2014
- Investigator
- Viviana Matta
- Observations
- 9
- Pages
- 6
- FEI number
- 3010078549
In short: On October 10, 2014, FDA issued a Form 483 with 9 observations to Stewart Compounding Pharmacy in Fayetteville, North Carolina (FEI 3010078549) after an inspection that ran Oct 6 – Oct 10, 2014. The investigator was Viviana Matta. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 7 of 9 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each batch of drug product purporting to be sterile is not laboratory tested to determine…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 03
Clothing ofpersonnel engaged in the processing ofdrng products is not appropriate fur the duties they perform…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Viviana Matta
17 documents · 2012–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmStewart Compounding Pharmacy history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.167
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stewart Compounding Pharmacy?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, production and quality system. The opening words of each observation are shown on this page.
Who inspected Stewart Compounding Pharmacy?
Viviana Matta is named on this Form 483, for the inspection of Oct 6 – Oct 10, 2014. Each investigator has a profile showing what they cite most.
When was Stewart Compounding Pharmacy inspected by FDA?
The inspection ran Oct 6 – Oct 10, 2014, and the Form 483 is dated October 10, 2014.
How do I get the full Form 483 for Stewart Compounding Pharmacy?
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.