# FDA 483 - Drug Depot, LLC., dba APS Pharmacy - June 17, 2022

Source: https://www.keypedia.com/records/483/drug-depot-llc-dba-aps-pharmacy/28708567-5203-47a7-8b88-a5e0660dfb5f

> FDA 483 for Drug Depot, LLC., dba APS Pharmacy on June 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Drug Depot, LLC., dba APS Pharmacy
- Inspection Date: 2022-06-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Drug Depot, LLC., dba APS Pharmacy in Palm Harbor, FL, a producer of sterile and non-sterile drug products, revealed significant deficiencies in aseptic processing and environmental controls. Observations included dirty equipment in ISO 5 areas, improper aseptic techniques, disrupted airflow due to personnel movements, inadequate smoke studies, and insufficient personnel monitoring. These conditions raise serious concerns regarding the sterility and quality of drug products manufactured at the facility.

## Related Documents

- [483 - 2016-01-22](https://www.keypedia.com/records/483/drug-depot-llc-dba-aps-pharmacy/5b6d37cc-fcde-4b82-b4b6-f9f188e608c9)
- [WARNING_LETTER - 2016-01-22](https://www.keypedia.com/records/warning_letter/drug-depot-llc-dba-aps-pharmacy/7fd8322b-185a-4b44-b8db-27ea132388f2)
- [483 - 2022-06-17](https://www.keypedia.com/records/483/drug-depot-llc-dba-aps-pharmacy/fb64ceda-205e-4b0c-92e8-f7ce4d98b32e)

## Related Officers

- [company_representative](https://www.keypedia.com/people/matt-parker/47867c3f-1f70-4e2c-901a-bca3aee5e2ff)
- [Saundra A. Munroe](https://www.keypedia.com/people/saundra-a-munroe/8e9b8973-5ac4-4a2a-ab26-1618c0e434e7)
- [Senior Manager, Executive Secretariat ](https://www.keypedia.com/people/jessica-m-simpson/94c06709-45cf-464f-92b4-ad3601ea20ab)

Company: https://www.keypedia.com/companies/drug-depot-llc-dba-aps-pharmacy/23539db0-0aec-4b57-b283-2d629437e19c

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6