# FDA 483 - Pharmedium Services LLC - December 09, 2010

Source: https://www.keypedia.com/records/483/pharmedium-services-llc/354f80ab-ba6a-47b7-9a8a-78e49396b824

> FDA 483 for Pharmedium Services LLC on December 09, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmedium Services LLC
- Inspection Date: 2010-12-09
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: An FDA Form 483 inspection revealed significant deficiencies at a facility compounding sterile preparations (CSPs). Between March 2010 and the present, the firm received approximately 11 complaints regarding Heparin-containing CSPs, citing subpotency and/or lack of therapeutic effect.

Specific complaints include:
*   January 8, 2010: "Heparin 25,000 Units added to 0.45% Sodium Chloride Injection (100 units/ml), lot #101029800022" for lack of therapeutic effect.
*   July 7, 2010: "Heparin 25,000 Units added to 5% Dextrose Injection USP (50 units/ml) 500ml Bag”, lot #101018200053" for subpotency.
*   May 17, 2010: "Heparin 25,000 Units added to 5% Dextrose Injection (50 units/ml), lot #101007800068" for lack of therapeutic effect.

Although complaint investigations included Certificates of Analysis from a contract laboratory indicating potency testing for Heparin using an (b)(4) method, the firm lacked data to demonstrate that this (b)(4) method

## Related Documents

- [483 - 2007-09-19](https://www.keypedia.com/records/483/pharmedium-services-llc/8c31b8b5-b0a1-47c9-b709-e37511ecb6ad)

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)

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