# FDA 483 - PharMEDium Services, LLC. - July 10, 2015

Source: https://www.keypedia.com/records/483/pharmedium-services-llc/bd789f97-8ccc-42d7-a910-a5dbb6f798a0

> FDA 483 for PharMEDium Services, LLC. on July 10, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PharMEDium Services, LLC.
- Inspection Date: 2015-07-10
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: This FDA Form 483 document outlines significant deficiencies observed during an inspection of a drug manufacturing facility, likely an outsourcing facility given the specific citation. The facility failed to thoroughly review batch failures or components not meeting specifications, even for distributed batches. Testing and release of drug products for distribution did not include appropriate laboratory determination of identity and strength for each active ingredient.

Building maintenance was deficient, as facilities were not kept in a clean and sanitary condition. Procedures to prevent microbiological contamination of sterile drug products were not followed and lacked validation of the sterilization process. Laboratory controls were inadequate, failing to establish scientifically sound specifications and test procedures to assure identity, strength, quality, and purity.

Aseptic processing areas had deficient environmental monitoring systems. Each batch of sterile and pyrogen-free drug product was not laboratory tested for conformance. The written stability program lacked meaningful and specific test methods. Furthermore, appropriate controls were not exercised over computer systems to ensure only authorized personnel instituted changes to master production and control records. Finally, the labels and containers of the outsourcing facility's drug products did not include information required by section 503B(a)(10)(A) and (B) of the FD&C Act. These findings indicate critical quality system and manufacturing issues, potentially impacting product sterility, quality, and regulatory compliance.

## Related Documents

- [483 - 2013-02-22](https://www.keypedia.com/records/483/pharmedium-services-llc/8bcf9fe1-7ee1-4312-a99e-1eebefde46e5)
- [483 - 2017-12-15](https://www.keypedia.com/records/483/pharmedium-services-llc/2106b3b3-f772-4f8f-8bf1-7e4e7aa6666d)
- [483 - 2018-01-05](https://www.keypedia.com/records/483/pharmedium-services-llc/a31cc90b-8f6f-4d6a-84b3-3b049e8fffd5)

## Related Officers

- [Supervisory Investigator at FDA](https://www.keypedia.com/people/zada-l-giles/29930e94-66c8-4d36-9220-b2ecbfe12351)
- [Ivy Sweeney](https://www.keypedia.com/people/ivy-sweeney/65ffe508-7309-4fa6-8a52-b599a0f90c33)

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