# FDA 483 - Pacira Pharmaceuticals, Inc. - March 01, 2018

Source: https://www.globalkeysolutions.net/records/483/pacira-pharmaceuticals-inc/8dc83423-7fcb-4574-9acc-8e9a26f243e3

> FDA 483 for Pacira Pharmaceuticals, Inc. on March 01, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pacira Pharmaceuticals, Inc.
- Inspection Date: 2018-03-01
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Pacira Pharmaceuticals, Inc. in San Diego, CA, received a Form 483 with six observations during an inspection from February 21 to March 1, 2018. The observations primarily concern inadequate investigations into discrepancies, deficiencies in cleaning and maintenance procedures, insufficient laboratory controls for microbial identification, and failures in supplier qualification and aseptic processing controls. The firm also failed to follow its own procedures for auditing critical and non-critical suppliers.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/allison-a-rodriguez/4298721f-e09d-4881-8e90-3277ceb17e7d)
- [https://www.fda.gov/media/120628/download](https://www.globalkeysolutions.net/people/santiago-gallardo-johnson/f5086b0c-c8fc-44dd-8d12-6506b9dd313f)
- [Anita Wenck](https://www.globalkeysolutions.net/people/anita-wenck/7f939937-cdc1-4aaa-b000-cd514996cdb3)

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

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