# FDA 483 - Pacira Pharmaceuticals, Inc. - April 19, 2023

Source: https://www.keypedia.com/records/483/pacira-pharmaceuticals-inc/c4669dc0-d3b3-4cbd-a077-ad61985c661a

> FDA 483 for Pacira Pharmaceuticals, Inc. on April 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pacira Pharmaceuticals, Inc.
- Inspection Date: 2023-04-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Pacira Pharmaceuticals, Inc. in San Diego, CA, a sterile manufacturer of human and animal drugs, revealed two significant issues. The firm failed to thoroughly investigate unexplained discrepancies and out-of-specification results, and did not adequately implement corrective and preventative actions. Additionally, records for calibration checks and equipment inspections, specifically cleanroom certification, were found to be deficient with individual measurements exceeding limits.

## Related Documents

- [483 - 2015-07-22](https://www.keypedia.com/records/483/pacira-pharmaceuticals-inc/57b5b6fb-1fd8-46b9-aa4d-73aa4e0ef8c5)
- [483 - 2018-03-01](https://www.keypedia.com/records/483/pacira-pharmaceuticals-inc/8dc83423-7fcb-4574-9acc-8e9a26f243e3)

## Related Officers

- [Rachel C. Stanton](https://www.keypedia.com/people/rachel-c-stanton/36495725-366c-4138-a4d8-df3ce38fa9cd)
- [Crystal Monroy](https://www.keypedia.com/people/crystal-monroy/b0414886-fb71-4f35-a453-0ad2baf13bfc)
- [Public Affairs Specialist](https://www.keypedia.com/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)

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