# FDA 483 - Ark Pharmacy, PC (dba Regency Medical Pharmacy) - February 24, 2022

Source: https://www.globalkeysolutions.net/records/483/ark-pharmacy-pc-dba-regency-medical-pharmacy/6de6bbea-a677-4e9f-ab63-15aa21341204

> FDA 483 for Ark Pharmacy, PC (dba Regency Medical Pharmacy) on February 24, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ark Pharmacy, PC (dba Regency Medical Pharmacy)
- Inspection Date: 2022-02-24
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Ark Pharmacy, PC (dba Regency Medical Pharmacy) in Newbury Park, CA, was inspected by the FDA from February 17-24, 2022. The inspection identified a significant quality control issue involving the use of non-pharmaceutical grade components in drug product formulation. Specifically, Arrowhead® distilled water was used in the compounding of non-sterile drug products.

## Related Officers

- [Scott N. Lim](https://www.globalkeysolutions.net/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

Company: https://www.globalkeysolutions.net/companies/ark-pharmacy-pc-dba-regency-medical-pharmacy/41587e9b-2dfe-4c78-bc20-4a4411701e41

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6