# FDA 483 - Intrathecal Compounding Specialists, LLC - Unknown Date

Source: https://www.keypedia.com/records/483/intrathecal-compounding-specialists-llc/03fdf69b-b44b-4ec0-9156-94076d3efca5

> FDA 483 for Intrathecal Compounding Specialists, LLC on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intrathecal Compounding Specialists, LLC
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Intrathecal Compounding Specialists, LLC in Scott, LA, a producer of sterile products, was cited for significant deficiencies during an FDA inspection. Observations included producing sterile drugs after air equipment changes without proper cleaning and recertification, inadequate pressure differentials in cleanrooms, and infrequent use of sporicidal agents. Additionally, the firm failed to perform adequate media fills and personnel exhibited improper gowning practices during aseptic operations.

## Related Documents

- [483 - 2017-11-17](https://www.keypedia.com/records/483/intrathecal-compounding-specialists-llc/43e1e50d-a604-4d68-8f78-f9e0d376ac05)
- [483_RESPONSE - 2017-11-17](https://www.keypedia.com/records/483_response/intrathecal-compounding-specialists-llc/15039468-9c60-4fa2-8cea-50ff96b84007)
- [483 - 2019-02-14](https://www.keypedia.com/records/483/intrathecal-compounding-specialists-llc/451be56b-6d07-456b-9882-59152eca12f4)
- [483 - 2019-02-14](https://www.keypedia.com/records/483/intrathecal-compounding-specialists-llc/dbc5eae6-e741-444a-bdbb-22424f60edb7)
- [483 - 2021-08-19](https://www.keypedia.com/records/483/intrathecal-compounding-specialists-llc/d25bbf7f-a7a0-4885-adde-7fcd1492aa84)

## Related Officers

- [CO CDER OMQ](https://www.keypedia.com/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

Company: https://www.keypedia.com/companies/intrathecal-compounding-specialists-llc/0e3fd92e-10f3-4744-8338-d248d6291186

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea