# FDA 483 - Region Care, Inc. - March 20, 2014

Source: https://www.keypedia.com/records/483/region-care-inc/f615086b-28cf-4fdb-97bf-7e0631c21541

> FDA 483 for Region Care, Inc. on March 20, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Region Care, Inc.
- Inspection Date: 2014-03-20
- Product Type: Drugs
- Office Name: New York District Office
- Summary: This FDA Form 483 documents observations from an inspection, citing multiple deficiencies in the facility's operations related to sterile drug product compounding.

**Violations and Observations:**

*   **Inadequate Investigations:** The firm failed to thoroughly investigate the sterility failure of Protonix 80mg/100ml 0.9% NaCl, lot # 19P-12125112-R6, compounded on 12/12/2013, without identifying a root cause or performing a risk evaluation.
*   **Environmental Monitoring Failures:** Failing gloved fingertip sampling results from a pharmacy technician on 12/11/2013, 12/20/2013, and 02/03/2014 were not investigated for root cause, risk, or CAPA. This technician also compounded the failed Protonix batch.
*   **Deficient Environmental Monitoring Program:** The EM program lacks daily surface/viable air sampling in ISO-5 areas during compounding, does not monitor non-viable particles in ISO-5 areas under dynamic conditions, and has no EM during media fills. Viable air and surface samples from ISO-5 LAFWs are not incubated/checked as required. Air-pressure differentials between ISO-6, ISO-7, and unclassified areas are not monitored, despite manometers being present.
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## Related Documents

- [WARNING_LETTER - 2014-03-20](https://www.keypedia.com/records/warning_letter/region-care-inc/04ea7b26-3c30-47f8-8ffa-91487e0e53fd)
- [483 - 2016-06-10](https://www.keypedia.com/records/483/region-care-inc/9aaf3643-ae99-438a-8c9b-cbb888e27ea2)
- [STATE_REFERRAL_LETTER - 2016-05-18](https://www.keypedia.com/records/state_referral_letter/region-care-inc/14e11b0e-c619-4a7b-bf2f-4f182187ff04)

## Related Officers

- [Biotechnology Specialist at FDA](https://www.keypedia.com/people/robert-c-horan/81b78f43-200d-4eaa-a586-fe2101759ffd)
- [Robert C. Steyert](https://www.keypedia.com/people/robert-c-steyert/8ebd3758-8970-411b-8281-5297de05ce48)

Company: https://www.keypedia.com/companies/region-care-inc/124455f2-1c87-4d62-bc05-cd527b2b92a2

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d