First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy

Form 483 issued August 11, 2021 · Mesa, Arizona

Inspection: Jul 14, 2021
Investigator: Christopher M. Jenner
Observations: 15
Pages: 9
FEI number: 3015235235

In short: On August 11, 2021, FDA issued a Form 483 with 15 observations to First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy in Mesa, Arizona (FEI 3015235235) after an inspection that ran Jul 14, 2021. The investigator was Christopher M. Jenner. 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 10 of 14 observations.

Production5

Facilities & equipment5

Laboratory controls3

Materials1

Most cited: 21 CFR 211.113 (5×) · 211.67 (2×)

What FDA observed

Preview: the opening words of each observation

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

01
21 CFR 211.113
The (b) <4> intended to render final product sterile was…
02
21 CFR 211.113
(6) -(4) I testing to the [(6) -(4)…
03
21 CFR 211.113
The cycle parameters (temperature, pressure and time) used for (6) (4) are not lethal to heat-resistant…
04
21 CFR 211.113
Observation 4: scanned text, readable in the full document.

11 more observations

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

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This inspection in context

The investigator

Christopher M. Jenner

11 documents · 2017–2022

Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Arizona.

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

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 15 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 First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy?

Christopher M. Jenner is named on this Form 483, for the inspection of Jul 14, 2021. 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 Jul 14, 2021, and the Form 483 is dated August 11, 2021.

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.