# FDA 483 - Hospira, Inc. - June 17, 2011

Source: https://www.keypedia.com/records/483/hospira-inc/82896c82-4b42-450b-bb14-c9eb1b79cac1

> FDA 483 for Hospira, Inc. on June 17, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hospira, Inc.
- Inspection Date: 2011-06-17
- Product Type: Devices
- Office Name: Atlanta District Office
- Summary: This FDA Form 483, issued to Hospira, Inc., a pharmaceutical and device manufacturer and gamma irradiator in Rocky Mount, NC, following an inspection from May 16 to June 17, 2011, details 18 observations of objectionable conditions.

Key issues include:
*   **Quality System Deficiencies:** No written stability testing program for drug products, specifically lacking routine sterility and container-closure integrity testing. The "Maintenance of Sterility" (MOS) program lacks justification for its representative sampling.
*   **Quality Control Unit Failures:** Contradictory instructions in MOS procedures and inadequate review of cross-contamination incidents (Dexmedetomidine HCL Injection).
*   **Investigation Failures:** Inadequate review of unexplained discrepancies and out-of-specification (OOS) results, including a sterilization failure (Lidocaine Hydrochloride) and a stability failure (Magnesium Sulfate). OOS laboratory results were dismissed without scientific justification (Dopamine HCl, Atropine Sulfate). Investigations did not extend to other potentially affected drug products (Sodium Chloride Injections).
*   **Contamination Control:** Deficient separate/defined areas and control systems, with bulk APIs (desmopressin, calcitrol) improperly stored and inconsistently coded in inventory.
*   **Equipment and Facility Issues:** Equipment not of appropriate design or suitably located, leading to operational difficulties and potential contamination (e.g., aseptic fill

## Related Documents

- [483 - 2010-01-19](https://www.keypedia.com/records/483/hospira-inc/3365c585-9a89-490b-8017-59eec2c09af5)
- [483 - 2018-02-02](https://www.keypedia.com/records/483/hospira-inc/fe237d3b-7ac6-4cc0-a546-a4c2899ac024)
- [483 - 2019-11-21](https://www.keypedia.com/records/483/hospira-inc/e86d25f7-dbfb-46b3-a9cc-424f1d165750)
- [483 - 2011-08-04](https://www.keypedia.com/records/483/hospira-inc/e0d8b125-2d3c-41d0-bd52-31ea75e878f3)
- [483 - 2012-07-26](https://www.keypedia.com/records/483/hospira-inc/ecb9d0a0-1284-4b8c-89ac-f3ce4b72c2cb)

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Company: https://www.keypedia.com/companies/hospira-inc/d4decc1e-4b42-43bb-be2c-abcefbc7b965

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7