# FDA 483 - Hospira, Inc. - August 04, 2011

Source: https://www.keypedia.com/records/483/hospira-inc/e0d8b125-2d3c-41d0-bd52-31ea75e878f3

> FDA 483 for Hospira, Inc. on August 04, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hospira, Inc.
- Inspection Date: 2011-08-04
- Product Type: Drugs
- Office Name: Atlanta District Office
- Summary: The FDA Form 483 details significant deficiencies in the firm's quality system, particularly concerning laboratory investigations and data integrity. The primary violation is the failure to thoroughly review batch failures and out-of-specification (OOS) or out-of-target (OOT) laboratory results, as required by SOP QCP 05.002, Laboratory Investigations Procedure.

Multiple instances of inadequate investigations were cited for various drug products, including Atropine Sulfate Injection, Quetiapine Injection, Dobutamine HCl Injection, Precedex Injection, Heparin Sodium in 0.45% Sodium Chloride Injection, Succinylcholine Chloride Injection, Desmopressin Acetate Injection, Ropivacaine HCl Injection, and Dopamine HCl in 5% Dextrose Injection. Common issues included invalidating OOS results without scientific justification or a clearly assignable laboratory error, lack of concurrent manufacturing assessments during laboratory investigations, and the release of lots that did not meet specifications based on unjustified stability analyses (e.g., Heparin Sodium).

The firm also improperly utilized an unapproved laboratory investigation form (WCQLIR) for both in-process and finished product testing, which allowed data invalidation without formal investigation. A new corporate SOP (QC.01.00.006, Laboratory Data Handling Practices Procedure) implemented on 3/31/11, which permits data invalidation under certain conditions, directly conflicts with SOP QCP.

## Related Documents

- [483 - 2011-06-17](https://www.keypedia.com/records/483/hospira-inc/82896c82-4b42-450b-bb14-c9eb1b79cac1)
- [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 - 2012-07-26](https://www.keypedia.com/records/483/hospira-inc/ecb9d0a0-1284-4b8c-89ac-f3ce4b72c2cb)

## Related Officers

- [Chemist](https://www.keypedia.com/people/daphne-santiago/8d875abe-9ff5-408d-addf-6d07d07767cf)
- [Penny MoCarver](https://www.keypedia.com/people/penny-mocarver/cadb8f76-a86a-47a1-ac3a-5c09860cac24)

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