FDA Intel

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
11
Pages
13
FEI number
3008723337

In short: On December 14, 2012, FDA issued a Form 483 with 11 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 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 7 of 11 observations.

Laboratory controls4
Production3
Facilities & equipment2
Materials2

Most cited: 21 CFR 211.113 (2×) · 211.84 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 211.167

    Each batch of drug product required to be free of objectionable microorganisms is not tested…

  2. 02
    21 CFR 211.160

    Established test procedures are…

  3. 03
    21 CFR 211.16621 CFR 211.137

    There is no written testing program designed to assess the…

  4. 04
    21 CFR 211.165

    Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…

7 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

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 firm

RX 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 483s

Other 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 11 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. 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.

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