RX South DBA RX3 Compounding Pharmacy LLC
Form 483 issued May 6, 2016 · Chester, Virginia
- Inspection
- Apr 11 – Apr 18, 2016
- Investigators
- Haijing Hu· Linda F. Murphy· Stacie Woods
- Observations
- 6
- Pages
- 4
- FEI number
- 3008723337
In short: On May 6, 2016, FDA issued a Form 483 with 6 observations to RX South DBA RX3 Compounding Pharmacy LLC in Chester, Virginia (FEI 3008723337) after an inspection that ran Apr 11 – Apr 18, 2016. The investigators were Haijing Hu, Linda F. Murphy and Stacie Woods. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 5 of 6 observations.
Most cited: 21 CFR 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 systems for maintaining any equipment used to…
- 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
Aseptic processing areas are deficient regarding the system…
This inspection in context
Haijing Hu
2 documents · 2016–2017
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arkansas.
The firmRX South DBA RX3 Compounding Pharmacy LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RX South DBA RX3 Compounding Pharmacy LLC?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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 RX South DBA RX3 Compounding Pharmacy LLC?
Haijing Hu, Linda F. Murphy and Stacie Woods are named on this Form 483, for the inspection of Apr 11 – Apr 18, 2016. Each investigator has a profile showing what they cite most.
When was RX South DBA RX3 Compounding Pharmacy LLC inspected by FDA?
The inspection ran Apr 11 – Apr 18, 2016, and the Form 483 is dated May 6, 2016.
How do I get the full Form 483 for RX South DBA RX3 Compounding Pharmacy 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.