# FDA 483 - Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy - February 20, 2020

Source: https://www.globalkeysolutions.net/records/483/innovative-intrathecal-solutions-inc-dba-innovative-compounding-pharmacy/96c70997-6179-409e-a18b-73b375f0bc30

> FDA 483 for Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy on February 20, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
- Inspection Date: 2020-02-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy in Murrieta, CA, revealed significant deficiencies in their sterile and non-sterile drug production. Observations included visibly dirty aseptic processing areas, inadequate HEPA filter coverage, insufficient cleaning and disinfection, and the use of non-pharmaceutical grade components. The firm also failed to adequately monitor the environment and conduct appropriate media fills, raising concerns about product sterility and cross-contamination.

## Related Documents

- [483 - 2020-02-20](https://www.globalkeysolutions.net/records/483/innovative-intrathecal-solutions-inc-dba-innovative-compounding-pharmacy/2a6ea583-833c-4834-8209-e5d2f171c284)
- [483 - 2021-10-26](https://www.globalkeysolutions.net/records/483/innovative-intrathecal-solutions-inc-dba-innovative-compounding-pharmacy/9c379bde-20ef-442b-a134-c307b9264bb8)

## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

Company: https://www.globalkeysolutions.net/companies/innovative-intrathecal-solutions-inc-dba-innovative-compounding-pharmacy/facccdb0-f578-40dc-b0e7-5a7ace70b3a0

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