Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3015235235.
Observations14
Issue DateAugust 11, 2021
Status1 Related Warning Letter
Establishment TypeProducer of Sterile and Non Sterile Drug Products
Related Inspections3
Establishment Details
Firm
First Royal Care Co. LLC, dba Red Mountain Compounding
Location
Mesa, Arizona, United States
FEI Number
3015235235
Establishment Type
Producer of Sterile and Non Sterile Drug Products
Product Type
Drugs
Issue Date
August 11, 2021
Country
United States
Inspection History, 2019 to 2022
VAI1
OAI2
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.