# FDA 483 - Pharmedium Services LLC - September 19, 2007

Source: https://www.keypedia.com/records/483/pharmedium-services-llc/8c31b8b5-b0a1-47c9-b709-e37511ecb6ad

> FDA 483 for Pharmedium Services LLC on September 19, 2007. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmedium Services LLC
- Inspection Date: 2007-09-19
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 document details observations from an inspection of a firm manufacturing sterile drug products.

**Key Observations:**

*   **Sampling and Testing Plan Deficiencies:** The firm's sampling and testing plan for sterility and potency of manufactured sterile drug products lacks assurance that statistical criteria and specifications are met. The sampling volume is not representative of total lots produced.
*   **Sanitization Procedure Inadequacies:** The procedure for sanitizing supplies and equipment used in sterile drug product manufacturing does not ensure adequate sanitization with a secondary method using a redacted substance. The firm has not evaluated the appropriateness of sanitizing surfaces of redacted bags of redacted drug products.
*   **Disinfectant Effectiveness Study Deficiencies:** Disinfectant effectiveness studies do not include microbial challenge (microbial recovery) studies to demonstrate the effectiveness of redacted and redacted as sanitizing agents in the interior of Class 100 Laminar Flow Hoods used for sterile drug production.
*   **Lack of On-going Stability Studies:** The firm does not conduct on-going stability studies for any finished drug products manufactured and distributed, failing to assure the validity of established expiry dates (15, 30, and 45 days).
*   **Absence of Incoming Material Analytical Testing:** Procedures do not require analytical testing of incoming, commercially available drug products (e.g., Magnesium Sulfate for Injection USP, Cefazolin for Injection USP, Oxytocin for Injection USP, Sterile Vancom

## Related Documents

- [483 - 2010-12-09](https://www.keypedia.com/records/483/pharmedium-services-llc/354f80ab-ba6a-47b7-9a8a-78e49396b824)

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)
- [Cso](https://www.keypedia.com/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

Company: https://www.keypedia.com/companies/pharmedium-services-llc/5bd462fe-ac25-43c0-9d15-ee36a092cf5c

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