# FDA 483 - Pacira Pharmaceuticals, Inc. - July 22, 2015

Source: https://www.keypedia.com/records/483/pacira-pharmaceuticals-inc/57b5b6fb-1fd8-46b9-aa4d-73aa4e0ef8c5

> FDA 483 for Pacira Pharmaceuticals, Inc. on July 22, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pacira Pharmaceuticals, Inc.
- Inspection Date: 2015-07-22
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Pacira Pharmaceuticals, Inc. in San Diego, CA, a drug manufacturer, revealed significant deficiencies across its facilities, equipment, production, and laboratory control systems. The firm failed to adequately maintain and qualify equipment, lacked proper cleaning procedures for stability chambers, and exhibited shortcomings in its investigation of discrepancies and documentation practices. These issues indicate a lack of adherence to current Good Manufacturing Practices, potentially impacting drug product quality and safety.

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## Related Officers

- [Chef de projet](https://www.keypedia.com/people/paul-a-bonneau/6c27155a-ce78-47d4-b692-0611fe0f9c44)
- [investigator](https://www.keypedia.com/people/virgilio-f-pacio/9d957c91-b8e9-4e71-ba2e-19b3eccd0e38)
- [Theresa Kirkham](https://www.keypedia.com/people/theresa-kirkham/c7d8aad0-d162-4fac-a1ba-4649c36fd714)

Company: https://www.keypedia.com/companies/pacira-pharmaceuticals-inc/0062419b-850d-4eea-ad5d-918907be2e52

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6