First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy

Form 483 issued September 12, 2022 · Mesa, Arizona

Inspection: Aug 29, 2021 – Sep 12, 2022
Investigator: Christopher M. Jenner
Observations: 3
Pages: 3
FEI number: 3015235235

In short: On September 12, 2022, FDA issued a Form 483 with 3 observations to First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy in Mesa, Arizona (FEI 3015235235) after an inspection that ran Aug 29, 2021 – Sep 12, 2022. The investigator was Christopher M. Jenner. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

3 of 3 observations on this 483 concern facilities & equipment.

Facilities & equipment3

Most cited: 21 CFR 211.42 (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 211.42
ISO-5 classified areas were not…
02
21 CFR 211.63
The ISO 5 classified equipment has…
03
21 CFR 211.42 21 CFR 211.67
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils and/or…

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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 211.42

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 3 observations on this Form 483, mostly about facilities & equipment. 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?

Christopher M. Jenner is named on this Form 483, for the inspection of Aug 29, 2021 – Sep 12, 2022. 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 Aug 29, 2021 – Sep 12, 2022, and the Form 483 is dated September 12, 2022.

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

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