RX South DBA RX3 Compounding Pharmacy LLC
Form 483 issued February 21, 2014 · Chester, Virginia
- Inspection
- Jan 24 – Feb 21, 2014
- Investigator
- Brooke K. Higgins
- Observations
- 11
- Pages
- 5
- FEI number
- 3008723337
In short: On February 21, 2014, 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 Jan 24 – Feb 21, 2014. The investigator was Brooke K. Higgins. 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 8 of 11 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for…
This inspection in context
Brooke K. Higgins
5 documents · 2011–2014
Cites 211.42(c)(10) (design and construction features) 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(b)
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 production, facilities & equipment and quality system. 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 RX South DBA RX3 Compounding Pharmacy LLC?
Brooke K. Higgins is named on this Form 483, for the inspection of Jan 24 – Feb 21, 2014. 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 Jan 24 – Feb 21, 2014, and the Form 483 is dated February 21, 2014.
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.