# 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/2a6ea583-833c-4834-8209-e5d2f171c284

> 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: Los Angeles District Office
- Summary: This FDA Form 483 document details observations from an inspection of an unnamed facility involved in aseptic processing. The inspection revealed several deficiencies related to facility control, cleaning, personnel practices, material handling, and quality systems.

Key observations include:
*   **Facility and Equipment:** ISO 5 classified aseptic processing areas contained visibly dirty and difficult-to-clean equipment or surfaces. There was inadequate HEPA filter coverage and airflow over areas where sterile product was exposed.
*   **Cleaning and Disinfection:** The firm failed to conduct adequate cleaning and disinfection in aseptic processing areas. Materials or supplies were not disinfected prior to entering these areas.
*   **Personnel Practices:** Personnel engaged in aseptic processing were observed with exposed hair.
*   **Material Quality:** A (b)(4) intended to render the final product sterile was not pharmaceutical grade. A non-pharmaceutical grade component was used in the formulation of a drug product.
*   **Quality Control and Monitoring:** Environmental monitoring was inadequately performed in aseptic processing areas. Media fills were not performed to closely simulate aseptic production operations, nor did they incorporate worst-case activities and conditions to challenge aseptic operations.

These observations indicate significant issues with maintaining a sterile environment, controlling critical inputs, and validating aseptic processes, potentially impacting the sterility and quality of drug products.

## Related Documents

- [483 - 2020-02-20](https://www.globalkeysolutions.net/records/483/innovative-intrathecal-solutions-inc-dba-innovative-compounding-pharmacy/96c70997-6179-409e-a18b-73b375f0bc30)
- [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/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b