# FDA 483 - Home Intensive Care Pharmacy, Inc. - March 01, 2013

Source: https://www.keypedia.com/records/483/home-intensive-care-pharmacy-inc/90599849-9cdb-4b0a-a2fb-25e7e07df46f

> FDA 483 for Home Intensive Care Pharmacy, Inc. on March 01, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Home Intensive Care Pharmacy, Inc.
- Inspection Date: 2013-03-01
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 details multiple deficiencies at a facility producing sterile drug products, including intrathecal medications like Morphine/Bupivacaine.

**Violations and Observations:**

*   **Aseptic Procedures:** The firm lacks written procedures for aseptic operations in ISO 5 and ISO 7 areas. A pharmacist was observed resting elbows on an ISO 5 laminar air-flow hood workbench and had exposed forearm skin due to a gap between non-sterile lab coat sleeves and sterile gloves during aseptic filling.
*   **Gowning Requirements:** Gowning procedures are inadequate and not formally documented for ISO 8, ISO 7, and ISO 5 areas. Observed gowning (single sterile gloves, non-sterile shoe covers, non-sterile lint-free lab coat, hair net, ear-loop face mask) left exposed skin around eyes, forehead, and neck during sterile drug processing.
*   **Facility and Equipment Design:** No evaluation of equipment contact surfaces or facility layout to prevent contamination in classified areas. ISO 5 laminar air-flow hood workbenches are made of particle board with a laminated surface. Smoke studies and pressure differential limits for ISO 5, ISO 7, and ISO 8 areas were only performed under static conditions, not dynamically. Pressure differentials between ISO 7 and ISO 8 are not actively monitored, and no limits are set; no apparent difference in pressure readings was observed, along with a spatial gap in the doorway between

## Related Documents

- [WARNING_LETTER - 2013-03-01](https://www.keypedia.com/records/warning_letter/home-intensive-care-pharmacy-inc/10f0cca8-5fb7-4997-80ac-2905be00230a)
- [483 - 2015-05-05](https://www.keypedia.com/records/483/home-intensive-care-pharmacy-inc/379349f6-65d5-4d34-b217-c4652029aa25)
- [STATE_REFERRAL_LETTER - 2015-04-20](https://www.keypedia.com/records/state_referral_letter/home-intensive-care-pharmacy-inc/3e131bce-c606-4b19-82c1-75b57183076a)

## Related Officers

- [Compliance Officer at FDA](https://www.keypedia.com/people/christopher-d-leach/2a3c4b73-f082-4f33-aa2d-52d1abbb6d55)
- [Investigator](https://www.keypedia.com/people/lucas-b-leake/f4c191d4-25d1-4eb8-8dc9-4d1aa483a441)

Company: https://www.keypedia.com/companies/home-intensive-care-pharmacy-inc/430b3469-86f5-4af3-93b1-b8eef88c2951

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9