# FDA 483 - Coastal Meds, LLC - September 23, 2015

Source: https://www.keypedia.com/records/483/coastal-meds-llc/80e659a9-2964-4a1a-8d9e-7741decca896

> FDA 483 for Coastal Meds, LLC on September 23, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Coastal Meds, LLC
- Inspection Date: 2015-09-23
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: The FDA Form 483 details multiple deficiencies at an outsourcing facility producing sterile drug products.

**Facility and Operations:** The facility manufactures sterile drug products, including Lipo-Den Extreme, Pyridoxine, Lipo-Plex, Lipo-Den, Lipo-Den Plus, Cyanocobalamin, Methylcobalamin, Hydroxocobalamin, Lipo-Den Max, Rodex, Adeno-Plex, and Methyl-Plex.

**Violations and Observations:**

*   **Aseptic Processing Area Deficiencies:**
    *   Environmental monitoring (surface and air) of the ISO 5 environment (room and laminar flow hood) is not performed daily when sterile products are produced, contrary to procedure 1114-02.
    *   Pressure differentials between the ante room (ISO 7) and clean room (ISO 5), and between the ante room and non-classified area, are not monitored due to absent gauges, despite procedure 1114-04.
    *   No evidence of constant airflow pressure in the ante room with a sink near the ISO 5 room.
    *   ISO 5 environment certification does not occur under dynamic conditions.
    *   Observed approximately 1-inch air gaps at the bottom of doors to the ante room and from the ante room to the ISO 5 room.
*   **Personnel Clothing:** Employees wore

## Related Documents

- [483 - 2014-11-10](https://www.keypedia.com/records/483/coastal-meds-llc/cc6169f7-4ea4-45aa-b846-1dc52c2a5707)
- [483 - 2018-04-06](https://www.keypedia.com/records/483/coastal-meds-llc/46441510-0f09-445b-83da-76470916eeed)
- [OTHER_CORRESPONDENCE - 2018-03-12](https://www.keypedia.com/records/other_correspondence/coastal-meds-llc/7e561015-e211-4247-b9d7-521e65085206)

## Related Officers

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

Company: https://www.keypedia.com/companies/coastal-meds-llc/f706471c-fa72-4716-8baa-e7d25c232a50

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