U.S. FOOD & DRUG 

VIA EMAIL CONFIRMED DELIVERY

February 13, 2023

Kamlesh Gandhi

Executive Director

Arizona State Board of Pharmacy

PO Box 18520

Phoenix, AZ 85005

Dear Dr. Gandhi,

The purpose of this letter is to refer to you, the Arizona State Board of Pharmacy for

appropriate follow up, the U.S. Food and Drug Administrations concerns about poor

sterile practices observed during an FDA inspection at a pharmacy you licensed, First

Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, located at 6828 E.

Brown Rd., Ste 101, Mesa, AZ 85207, FEI: 3015235235.

The FDA inspected the firm from August 29, 2022, to September 12, 2022. You were

informed of the inspection but did not accompany FDA investigators during the

inspection.

A copy of a Form FDA 483 that documents our investigators observations from the

inspection can be found at https://www.fda.gov/media/164854/download, with any 

nonpublic information redacted. Because we consider this inspection to be closed

under 21 CFR 20.64(d)(3), you may request a copy of the Establishment Inspection

Report (EIR) that the FDA will provide to the firm, which contains additional information

about our inspection. If your state agency has entered into a 21 CFR 20.88 information

sharing agreement, you may be able to receive a copy of the Form FDA 483 and/or the

EIR that includes certain nonpublic information. You may also choose to request such

documentation directly from the firm. 

During the inspection, the FDA investigator reviewed a small sample of records for drug

products compounded by First Royal Care Co. LLC, dba Red Mountain Compounding

Pharmacy and the FDA does not intend to take further actions at this time related to

conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

During the inspection, the FDA investigator observed deviations from appropriate

practice standards that, if not corrected, could lead to contamination of drugs, potentially 

putting patients at risk. Examples of deviations observed during our inspection include:

1. The firm did not perform dynamic smoke studies for their ISO Class 5 LAFW

Division of Pharmaceutical Quality Operations IV

19701 Fairchild, Irvine CA 92612-2506

Telephone: 949-608-2900

Fax: 949-608-4417

www.fda.gov
(laminar airflow workstation), which is used to produce all hazardous (hormone)

sterile drug products since approximately April 2022. In addition on 09/01/22

the ead s terile t echnician stated they sealed a circular opening on the back 

panel of the ISO Class 5 LAFW when it was installed around April 2022. No

studies have been performed to ensure the sealed opening does not leak or

disrupt laminar airflow. Since approximately 05/31/2022, the firm has produced

and dispensed hazardous sterile drug products using this ISO Class 5 LAFW.

2. The back panel of the ISO Class 5 LAFW, which is used to produce all

hazardous (hormone) sterile drug products since approximately April 2022, was

observed to be difficult to clean. On 09/01/22, the ead s terile t echnician stated

that the surface is used to cover the mounting holes of lamps. ISO class 5

equipment should be completely smooth and easy to clean.

3. The firms procedure titled Cleanroom Equipment Cleaning, version one, dated

03/18/22, does not include a deactivation agent when cleaning equipment and

utensils used to produce hazardous sterile drug products. The equipment and

utensils are non-dedicated and are used to produce both hazardous and nonhazarous sterile drug products. Since approximately 05/31/2022, the firm has

produced and dispensed sterile drug products, which include hazardous sterile

drug products.

Page 2

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy committed to the

FDA in its response to the Form FDA 483, dated September 30, 2022, to correct the

deviations in the Form FDA 483 and provided documentation in support of those

corrective actions. In addition, the deviations identified appear to be readily correctable.

After review of the records, the FDA does not intend to take further action at this time

with regard to the findings of this inspection. The FDA believes that the corrective

actions can be appropriately overseen by the S tate of Arizona . Therefore, the FDA is 

referring this matter to you for follow up to ensure appropriate corrective action has 

been taken. We believe you, the State, are in the best position to conduct follow-up and

routine regulatory activities at this firm to ensure the ongoing quality of drug products

they produce. Please notify us if you become aware of any adverse events or product

quality concerns associated with drug products made at this facility, or if you observe

any practices at this facility that concern you or that could be violations of Federal law.

We look forward to continuing to work with you on the oversight of compounding

pharmacies. If you have additional questions, please contact Andrew Haack,

compliance officer, at 206-340-8212, or by email at Andrew.Haack@fda.hhs.gov.

Please reference the FEI number cited above when contacting us.

www.fda.gov
Sincerely,

CDR Steven E. Porter, Jr.

Director, Division of Pharmaceutical Quality Operations IV

Page 3

SP: ah

Cc: Dawn T. Hoang

Co-owner

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

6828 E. Brown Rd., Ste 101

Mesa, AZ 85207

www.fda.gov