Stewart Compounding Pharmacy
Form 483 issued February 26, 2014 · Fayetteville, North Carolina
- Inspection
- Feb 18 – Feb 26, 2014
- Investigators
- Bonita S. Chester· Tamara J. Henderson
- Observations
- 3
- Pages
- 2
- FEI number
- 3010078549
In short: On February 26, 2014, FDA issued a Form 483 with 3 observations to Stewart Compounding Pharmacy in Fayetteville, North Carolina (FEI 3010078549) after an inspection that ran Feb 18 – Feb 26, 2014. The investigators were Bonita S. Chester and Tamara J. Henderson. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (2×) · 211.28(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Clothing of personnel engaged in the processing of drug products is not appropriate for…
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 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stewart Compounding Pharmacy?
FDA listed 3 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Stewart Compounding Pharmacy?
Bonita S. Chester and Tamara J. Henderson are named on this Form 483, for the inspection of Feb 18 – Feb 26, 2014. Each investigator has a profile showing what they cite most.
When was Stewart Compounding Pharmacy inspected by FDA?
The inspection ran Feb 18 – Feb 26, 2014, and the Form 483 is dated February 26, 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.