# FDA 483 - PharMEDium Services, LLC - December 22, 2017

Source: https://www.keypedia.com/records/483/pharmedium-services-llc/7a338946-16bf-4e74-8eb6-973e75ec9d40

> FDA 483 for PharMEDium Services, LLC on December 22, 2017. Product: N/A. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: PharMEDium Services, LLC
- Inspection Date: 2017-12-22
- Office Name: Dallas District Office
- Summary: This FDA Form 483 details significant deficiencies at an outsourcing facility, impacting its quality control, manufacturing, and laboratory operations.

**Key Violations and Observations:**

*   **Quality Control Unit Deficiencies:** The quality control unit lacks the authority to reject drug products.
*   **Contamination Control Issues:** The facility layout is not designed to prevent contamination. Procedures for preventing microbiological contamination of sterile drug products are inadequate, lacking proper validation of aseptic processing.
*   **Investigation Failures:** The firm failed to thoroughly investigate unexplained discrepancies or batch failures, including incomplete investigations into 2017 sterility failures (e.g., no microorganism identification, no assessment of affected lots). A root cause was not determined for a Ropivacaine HCl lot that failed endotoxin testing. Investigations into over 100 microbial excursions in ISO 5 hoods (Aspergillus species) and 289 confirmed Out-of-Specification (OOS) potency results since January 2017 were incomplete or not closed, with corrective actions not implemented for the microbial excursions.
*   **Aseptic Processing Area Deficiencies:** Systems for maintaining equipment, cleaning/disinfecting rooms, and monitoring environmental conditions in aseptic processing areas are deficient. Environmental monitoring revealed the presence of Aspergillus, Cladosporium, and Rhizopus in ISO 5 hoods.
*   **Laboratory Control Issues:** Laboratory controls lack scientifically sound test procedures. Drug product samples for conformance testing are not

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)
- [Jason R. Caballero](https://www.keypedia.com/people/jason-r-caballero/c2c8d281-0d02-459f-9541-bc04cb6d0a59)

Company: https://www.keypedia.com/companies/pharmedium-services-llc/a123fe5a-4002-4915-95e4-1de935115d67

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9