First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy
FDA inspection history in Mesa, Arizona, 2019 to 2023
- 3
- Form 483s
- 2
- Close-outs
Every document, by year
- Close-out
- Form 483
2019: one Form 483; 2020: one close-out letter; 2021: one Form 483; 2022: one Form 483; 2023: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–23Three Form 483s and two close-out letters, at Mesa, Arizona.
- 2021The longest 483 on file: 15 observations over 9 pages at Mesa, Arizona.
Cited most
Across all First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.166Stability testing2
The complete First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Mesa, Arizona
Three Form 483s and two close-out letters · 2019 to 2023 · 30 observations
Latest: Close-out, Feb 13, 2023 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-02-13 | Close-out Close-out letter | Mesa, Arizona | — | $99 |
| 2022-09-12 | 483 Form 483 | Mesa, Arizona | 3 | $99 |
| 2021-08-11 | 483 Form 483 | Mesa, Arizona | 15 | $99 |
| 2020-09-08 | Close-out Close-out letter | Mesa, Arizona | — | $99 |
| 2019-06-14 | 483 Form 483 | Mesa, Arizona | 12 | $99 |
Investigators on these documents
FEI number 3015235235 · most recent document Feb 13, 2023
About First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy
How many FDA Form 483s has First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy received?
FDA Intel has 3 Form 483s on file for First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy; the most recent is dated Sep 12, 2022.
When was First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy is a Form 483 dated Sep 12, 2022, for the site in Mesa, Arizona.
What did FDA cite at First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy?
The regulations cited most in the observations on file for First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy are 21 CFR 211.113 (Control of microbiological contamination), 6 times; 21 CFR 211.42 (Design and construction features), 6 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times.