Stewart Compounding Pharmacy
Form 483 issued March 25, 2013 · Fayetteville, North Carolina
- Inspection
- Mar 18 – Mar 25, 2013
- Investigators
- Penny H. McCarver· Viviana Matta
- Observations
- 10
- Pages
- 8
- FEI number
- 3010078549
In short: On March 25, 2013, FDA issued a Form 483 with 10 observations to Stewart Compounding Pharmacy in Fayetteville, North Carolina (FEI 3010078549) after an inspection that ran Mar 18 – Mar 25, 2013. The investigators were Penny H. McCarver and Viviana Matta. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Laboratory controls and production account for 6 of 8 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
The written stability testing…
This inspection in context
Penny H. McCarver
3 documents · 2011–2013
Cites 211.42(a) (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 10 observations on this Form 483, mostly about laboratory controls, production and materials. 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?
Penny H. McCarver and Viviana Matta are named on this Form 483, for the inspection of Mar 18 – Mar 25, 2013. Each investigator has a profile showing what they cite most.
When was Stewart Compounding Pharmacy inspected by FDA?
The inspection ran Mar 18 – Mar 25, 2013, and the Form 483 is dated March 25, 2013.
How do I get the full Form 483 for Stewart Compounding Pharmacy?
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