# FDA 483 - Home Intensive Care Pharmacy, Inc. - May 05, 2015

Source: https://www.keypedia.com/records/483/home-intensive-care-pharmacy-inc/379349f6-65d5-4d34-b217-c4652029aa25

> FDA 483 for Home Intensive Care Pharmacy, Inc. on May 05, 2015. 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: 2015-05-05
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 details multiple deficiencies at a facility producing sterile drug products, including Bupivacaine/Lidocaine, Morphine/Clonidine, Vancomycin, Baclofen, Hydromorphone/Clonidine, and Fentanyl.

Key violations include:
1.  **Sterilization Process Validation:** Media fills do not adequately simulate actual production conditions, including various vial/syringe sizes and batch sizes. Syringe production is not assessed in current media fill validations. The incubator used for media fills lacks a written procedure for use/maintenance and temperature monitoring records.
2.  **Environmental Monitoring:** No written procedure for environmental monitoring of ISO 5 areas. Monitoring of ISO 5 laminar flow hoods and ISO 7 cleanroom is not performed during production. Viable air monitoring in ISO 7/ante/prep rooms is only done during certification, not routinely. ISO 5 laminar flow hoods lack viable air monitoring. Operator fingertip sampling is infrequent.
3.  **Cleaning and Disinfection:** Non-sterile wipes are used in ISO 5 laminar flow hoods. A sporicidal disinfectant is not used in ISO 5/ISO 7 areas. Components are not sprayed with disinfectant before entering ISO 5 hoods.
4.  **Personnel Gowning:** Gowning attire (scrubs donned outside, non-sterile lab coat, single hairnet, ear-loop mask) leaves exposed skin. Specific observations include a torn

## 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 - 2013-03-01](https://www.keypedia.com/records/483/home-intensive-care-pharmacy-inc/90599849-9cdb-4b0a-a2fb-25e7e07df46f)
- [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

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)
- [ Investigator ](https://www.keypedia.com/people/patrice-s-hall/b58acfc0-fa18-4425-9a51-92267a2a6491)

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