RX South DBA RX3 Compounding Pharmacy LLC
Form 483 issued December 14, 2012 · Chester, Virginia
- Inspection
- Dec 4 – Dec 14, 2012
- Investigator
- Rachel C. Harrington
- Observations
- 13
- Pages
- 8
- FEI number
- 3008723337
In short: On December 14, 2012, FDA issued a Form 483 with 13 observations to RX South DBA RX3 Compounding Pharmacy LLC in Chester, Virginia (FEI 3008723337) after an inspection that ran Dec 4 – Dec 14, 2012. The investigator was Rachel C. Harrington. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 9 of 13 observations.
Most cited: 21 CFR 211.113 (3×) · 211.84 (2×)
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 required to be free of objectionable microorganisms is not tested…
- 02
Established test procedures are…
- 03
There is no written testing program designed to assess the stability…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Rachel C. Harrington
7 documents · 2012–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Maryland.
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 13 observations on this Form 483, mostly about production, laboratory controls 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 RX South DBA RX3 Compounding Pharmacy LLC?
Rachel C. Harrington is named on this Form 483, for the inspection of Dec 4 – Dec 14, 2012. 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 Dec 4 – Dec 14, 2012, and the Form 483 is dated December 14, 2012.
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.