# FDA 483 - Pharmedium Services, LLC - May 26, 2016

Source: https://www.keypedia.com/records/483/pharmedium-services-llc/be691387-003c-427d-bd91-6ef709f07b92

> FDA 483 for Pharmedium Services, LLC on May 26, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmedium Services, LLC
- Inspection Date: 2016-05-26
- Product Type: Drugs
- Office Name: New Jersey District Office
- Summary: This FDA Form 483 details significant deficiencies at an outsourcing facility producing sterile drug products. The facility's aseptic processing areas, including ISO-5 laminar flow hoods and an ISO-7 Clean Room, lack adequate systems for maintaining aseptic conditions.

Key violations include:
*   **Environmental Control Deficiencies:** Uncalibrated pressure gauges for ISO-5 hoods, lack of continuous monitoring for ISO-7 HEPA units, and failure to consistently maintain positive pressure cascade from the ISO-7 Clean Room, with documented negative pressure excursions and no investigations.
*   **Aseptic Process Validation:** Smoke studies under dynamic conditions did not fully represent routine operations or personnel movement, and failed to demonstrate consistent airflow from the ISO-7 Clean Room when doors were opened.
*   **Product Testing Deficiencies:** Sterility testing is not performed for every batch of finished sterile drug product, with a significant percentage of batches not submitted for testing or having delayed results received after product expiration. Potency testing is also deficient.
*   **Cleaning and Disinfection:** Lack of scientific justification for the effectiveness of the sporicide and its contact time.
*   **Quality Control and Inspection:** Inadequate visual inspection process for particulate matter, no qualification process for visual inspection personnel, and no representative defect library for training.
*   **Component Control:** Incoming sterile components are not sampled, tested, or released by quality control, and supplier Certificates of Analysis are not routinely reviewed for critical attributes.

## Related Documents

- [483 - 2015-09-24](https://www.keypedia.com/records/483/pharmedium-services-llc/0e5b3c76-f017-4c17-a923-5d6931489802)
- [483 - 2015-07-16](https://www.keypedia.com/records/483/pharmedium-services-llc/e84e5ade-6469-4a83-9821-3344f6faba73)
- [483 - 2015-07-13](https://www.keypedia.com/records/483/pharmedium-services-llc/508b5cb2-c535-4f24-8c66-413ec0a53090)
- [483 - 2016-01-04](https://www.keypedia.com/records/483/pharmedium-services-llc/e7b67d64-4cfd-4b7d-8e22-de4ecc8e422e)
- [483 - 2013-02-27](https://www.keypedia.com/records/483/pharmedium-services-llc/e18039f2-fd62-422b-b61b-7ab2df91126c)

## Related Officers

- [Senior Compliance Officer](https://www.keypedia.com/people/barbara-wilimczyk-macri/36eda42e-09b6-4364-a000-c5cd8ddb70ee)

Company: https://www.keypedia.com/companies/pharmedium-services-llc/9b6f5bdb-3f56-46d7-8dce-984393afb298

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248