# FDA 483 - Home Care Pharmacy of Palm Coast, Inc. - May 25, 2016

Source: https://www.keypedia.com/records/483/home-care-pharmacy-of-palm-coast-inc/4d81eb8c-250c-4038-acb5-a9eedd5e9723

> FDA 483 for Home Care Pharmacy of Palm Coast, Inc. on May 25, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Home Care Pharmacy of Palm Coast, Inc.
- Inspection Date: 2016-05-25
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: An FDA Form 483 was issued following an inspection, identifying multiple deficiencies in aseptic processing, environmental control, personnel practices, product testing, and record-keeping.

The facility's aseptic processing areas were deficient in cleaning and disinfection. On May 17, 2016, a technician cleaned the ISO 5 area using non-sterile wipes and an incorrect cleaning agent (sterile water instead of 70% IPA), failing to follow SOP 3.020. The technician also lacked sterile gowning, with exposed hair contacting ISO 5 surfaces. No sporicidal agent was used for ISO 5 cleaning, and application times for cleaning solutions were undefined or insufficient per manufacturer recommendations (e.g., 1-minute application for a 10-minute fungicidal effectiveness requirement).

Environmental monitoring of the ISO 5 area and operator gloves was only performed quarterly, with no daily monitoring or in-process monitoring during sterile drug product production. Personnel clothing was inappropriate; on May 17, 2016, the technician cleaning the ISO 5 area wore only non-sterile gloves and a face mask, lacking sterile hair nets, gowns, or shoe covers.

Sterile drug products, including Alprostadil, Bi-Mix, Tri-Mix, Quad-Mix, Droperidol, Glutathione, Hydroxocobalamin, and Sodium Hydroxide, were not adequately tested for endotoxin levels and bioburden

## Related Documents

- [WARNING_LETTER - 2016-05-25](https://www.keypedia.com/records/warning_letter/home-care-pharmacy-of-palm-coast-inc/228a37a0-99a8-45bf-8b64-a990145b7540)
- [483 - 2018-04-25](https://www.keypedia.com/records/483/home-care-pharmacy-of-palm-coast-inc/6c4889ad-9778-4288-8599-0f79d74736dc)

## Related Officers

- [Investigator](https://www.keypedia.com/people/shelby-n-marler/2cbb1b1c-ad36-4385-b61f-bee80ad8e1bd)

Company: https://www.keypedia.com/companies/home-care-pharmacy-of-palm-coast-inc/953cbd10-2284-46ad-bb32-ffdf3c0e2c00

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9