# FDA 483 - PharMEDium Services, LLC. - January 05, 2018

Source: https://www.keypedia.com/records/483/pharmedium-services-llc/a31cc90b-8f6f-4d6a-84b3-3b049e8fffd5

> FDA 483 for PharMEDium Services, LLC. on January 05, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PharMEDium Services, LLC.
- Inspection Date: 2018-01-05
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: This FDA Form 483 documents multiple deficiencies at an outsourcing facility, indicating significant issues with sterile drug product manufacturing and quality control.

Key observations include:
*   **Microbiological Control:** Lack of established, written, and followed procedures to prevent microbiological contamination of sterile drug products.
*   **Process Validation:** Absence of control procedures to validate manufacturing processes affecting in-process material and drug product characteristics.
*   **Equipment Maintenance:** Failure to maintain equipment and utensils at appropriate intervals to prevent contamination.
*   **Aseptic Processing Deficiencies:**
    *   Inadequate environmental monitoring systems.
    *   Deficient systems for maintaining equipment used to control aseptic conditions.
    *   Inadequate cleaning and disinfecting procedures for rooms and equipment.
*   **Air Filtration:** The production area air supply lacks an appropriate air filtration system.
*   **Sampling:** Samples taken for conformance testing are not representative.
*   **Deviation Management:** Failure to thoroughly review unexplained discrepancies, even for distributed batches.
*   **Production & Process Controls:** No written procedures to assure drug product identity, strength, quality, and purity.
*   **Filtration Validation:** Unvalidated use of a (b)(4) for particulate removal during the (b)(4) process, with no compatibility determination or documentation in batch records.
*   **Container/Closure Issues:**
    *   Containers and closures not tested per written procedures.
    *   Container

## Related Documents

- [483 - 2013-02-22](https://www.keypedia.com/records/483/pharmedium-services-llc/8bcf9fe1-7ee1-4312-a99e-1eebefde46e5)
- [483 - 2015-07-10](https://www.keypedia.com/records/483/pharmedium-services-llc/bd789f97-8ccc-42d7-a910-a5dbb6f798a0)
- [483 - 2017-12-15](https://www.keypedia.com/records/483/pharmedium-services-llc/2106b3b3-f772-4f8f-8bf1-7e4e7aa6666d)

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)
- [Investigator](https://www.keypedia.com/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)

Company: https://www.keypedia.com/companies/pharmedium-services-llc/02f1e2a6-7ac8-4b47-84ec-c717373236bf

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