First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy

Form 483 issued June 14, 2019 · Mesa, Arizona

Inspection: Jun 5 – Jun 14, 2019
Investigator: Bryan L. McGuckin
Observations: 12
Pages: 7
FEI number: 3015235235

In short: On June 14, 2019, FDA issued a Form 483 with 12 observations to First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy in Mesa, Arizona (FEI 3015235235) after an inspection that ran Jun 5 – Jun 14, 2019. The investigator was Bryan L. McGuckin. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and laboratory controls account for 8 of 12 observations.

Facilities & equipment4

Laboratory controls4

Production3

Quality system1

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of diug products purporting to be sterile did not include…
02
21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
03
21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system…
04
21 CFR 211.42(c)(10)(iii)
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency paiiiculate air…

8 more observations

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

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This inspection in context

The investigator

Bryan L. McGuckin

30 documents · 2017–2026

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.

The firm

First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113(b)

See how FDA wrote the same problem up elsewhere.

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Questions about this 483

What did FDA find at First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy?

FDA listed 12 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. 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 First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy?

Bryan L. McGuckin is named on this Form 483, for the inspection of Jun 5 – Jun 14, 2019. Each investigator has a profile showing what they cite most.

When was First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy inspected by FDA?

The inspection ran Jun 5 – Jun 14, 2019, and the Form 483 is dated June 14, 2019.

How do I get the full Form 483 for First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy?

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.