# FDA 483 - Customcoatial Compounding, LLC - March 08, 2019

Source: https://www.keypedia.com/records/483/customcoatial-compounding-llc/036208a6-552c-4743-83c2-220e2e0eb2af

> FDA 483 for Customcoatial Compounding, LLC on March 08, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Customcoatial Compounding, LLC
- Inspection Date: 2019-03-08
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: This FDA Form 483 details multiple deficiencies in aseptic processing and quality control for sterile drug products, specifically intrathecal finished product lots.

**Key Violations and Observations:**

*   **Inadequate Microbiological Contamination Prevention:**
    *   Operator (b)(6) failed to sanitize individual packages inside a plastic bin immediately prior to introduction into the ISO 5 LAFW on 02/27/19 and 02/28/19, impacting multiple intrathecal lots.
    *   Both primary aseptic production operators (staff pharmacists (b)(6) and (b)(6)) failed their 01/24/19 media fills due to exceeding gloved fingertip CFU limits (4 CFU for (b)(6) and 8/6 CFU for (b)(6)). Despite failing, their records were marked "pass," and no deviations were opened. Both operators produced sterile products from 01/25/19 through 03/04/19 and 03/06/19, respectively. Operator (b)(6) also lacked routine personnel monitoring.
    *   Airflow visualization study for the LAFW (05/25/17) showed insufficient smoke, stagnation, and turbulence, and dynamic conditions were not representative of production.

*   **Deficient Environmental Monitoring and Action:**
    *   Operator (b)(6)'

## Related Documents

- [483 - 2019-03-08](https://www.keypedia.com/records/483/customcoatial-compounding-llc/4f701361-2ae3-4f4d-827f-0be98cd0d102)

## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)
- [Christopher M. Jenner](https://www.keypedia.com/people/christopher-m-jenner/d2fbd516-71aa-4263-8ffb-57b8149d6b64)

Company: https://www.keypedia.com/companies/customcoatial-compounding-llc/a64248b1-ed3d-402c-83a8-2a0efb554dc5

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face