Blue Ridge Pharmacy and Compounding Center
Form 483 issued October 23, 2013 · Raleigh, North Carolina
- Inspection
- Oct 15 – Oct 23, 2013
- Investigator
- Viviana Matta
- Observations
- 9
- Pages
- 6
- FEI number
- 3014033194
In short: On October 23, 2013, FDA issued a Form 483 with 9 observations to Blue Ridge Pharmacy and Compounding Center in Raleigh, North Carolina (FEI 3014033194) after an inspection that ran Oct 15 – Oct 23, 2013. The investigator was Viviana Matta. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 6 of 9 observations.
Most cited: 21 CFR 211.42 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
Procedures designed lo prevent microbiological contamination ofdrug producls purporting to be sterile are…
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 firmBlue Ridge Pharmacy and Compounding Center history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Blue Ridge Pharmacy and Compounding Center?
FDA listed 9 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Blue Ridge Pharmacy and Compounding Center?
Viviana Matta is named on this Form 483, for the inspection of Oct 15 – Oct 23, 2013. Each investigator has a profile showing what they cite most.
When was Blue Ridge Pharmacy and Compounding Center inspected by FDA?
The inspection ran Oct 15 – Oct 23, 2013, and the Form 483 is dated October 23, 2013.
How do I get the full Form 483 for Blue Ridge Pharmacy and Compounding Center?
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.